Clinnovo News

Company Showcase : Novo Nordisk India

2011-09-30T16:00:00.000-07:00

Novo Nordisk is headquartered in Denmark and the indian site is located in Bangalore. Novo Nordisk has pioneered the insulin pump and world leaders in diabetes area. For India they have aggressive growth plans (33% R&D for diabetes) and have a strong product portfolio for Indian market.

Careers visit
http://www.novonordisk.com/jobs/job_section/current_jobs.asp?slangid=uk&lCountry=325

ToxTools

2011-09-30T03:24:00.000-07:00

ToxTools is a Statistical Software for Toxicological Risk Assessment.

Features of ToxTools:

ToxTools is a complete solution for modeling and testing data from dose-response studies, and for estimating Benchmark Dose Levels (BMD's).

It provides modern, sophisticated modeling and estimation algorithms for fitting dose response data as part of a state-of-the-art suite of graphical and numeric analysis tools for toxicological risk assessment.

Availability of all standard dose response models (one-hit, logit, probit, Weibull and more).

Linear, polynomial and power regression models for continuous outcomes.

Dose response assessment of simultaneous and hierarchical multiple outcomes.

Analysis of correlated data using generalized estimating equations (GEE).

Trend and pairwise tests for binary or continuous outcomes.

Exact tests of trend for both uncorrelated and correlated outcomes in small data sets.

Single and multiple outcome risk estimation using Benchmark Dose methodology, with several methods for lower limit calculations.

Simple dialogs for model specification, intelligent recall to modify previous runs and check sensitivity to modeling assumptions.

Data summarization and exploratory graphics, tailored to the analysis of dose response data. Workbook-style interface for organization and comparison of results.

Publication quality graphics. Powerful, Excel-like data editor with variable creation, transformation, and case subsetting.

A Disaster In The Making : The emergence of new forms of drug resistant bacteria will threaten patients worldwide

2011-09-16T03:52:00.000-07:00

Research has shown that polluted rivers in India are flooded with bacteria that are resistant to many antibiotics.

Pollution is an omnipresent evil that modern day India confronts on a daily basis. And with rapid strides in industrialisation and lax government control we now face a pandemic of pollution affecting everything around us.Industrial effluents and chemicals often form the major portion of the lethal pollutants in our natural resources.

A new study by a group of Swedish scientists published in the recent version of PLoS ONE has shown how polluted rivers in India are flooded with bacteria with serious levels of drug resistance. In this particular example nearly 90 bulk drug manufacturing pharmaceutical companies were dumping the effluent/waste water from their factories into the waste water treatment plant in Patancheru, Hyderabad. Scientists have used a new method of DNA/genetic sequencing to show that bacteria present in this water are full of resistance genes that protect them from the currently available antibiotics.

Since the bacteria in the rivers are constantly exposed to moderate to high levels of antibiotics they develop a resistance by the modification of their genetic structure. Once the resistance genes are developed they are transmitted on small genetic cassettes or plasmids that can spread to other bacteria. Though some of the bacteria in the Indian rivers may not affect humans directly they can transfer their drug resistance genes to other harmful bacteria which can propagate these to humans. This will result in the emergence of new forms of bacteria like the recent discovery of New Delhi metallo-beta-lactamase-1 or NDM-1 (which was later renamed Plasmidencoding Carbapenem-resistant Metallobeta-Lactamase or PCM) which is resistant to most available antibiotics.

In combination with rampant misuse, self-medication and aggressive prescribing of antibiotics by the medical community we will continue to face the emergence of drug resistant bacteria that will threaten patients worldwide.

Desk job can double bowel cancer risk

2011-04-20T05:21:00.001-07:00

Here's bad news for those who sit in front of a computer all day at work.

A new study has suggested that spending 10 years or more in a desk job almost doubles the risk of bowel cancer, even if you regularly keep fit or go to the gym.

The findings highlight the dangers of modern working patterns, where large numbers of employees are desk bound for hours at a time, reports the Daily Mail.

The research also backs up earlier studies which showed men who sit down most of the day at their jobs are 30 per cent more likely to be diagnosed with prostate cancer than those with very active occupations.

Diets high in fat and red meat, as well as lack of exercise, are thought to be among the main risk factors.

But the latest study, by a team of experts at the University of Western Australia, show long periods of physical inactivity during the day could also be a major risk.

The researchers spoke to 918 bowel cancer victims and compared their working patterns with 1,021 cancer-free volunteers.

They were quizzed on their job history, lifestyles and levels of physical activity.

The results showed employees who spent more than a decade in sedentary jobs were 94 per cent more likely to suffer a tumour in an area of the bowel known as the distal colon.

This is a large part of the bowel which connects up with the rectum. Researchers also found sedentary working patterns increased the chances of cancer of the rectum by 44 per cent over a 10-year period.

They said that their findings suggest no amount of leisure time activity can offset the harm done from long periods of sitting down on the job.

"We found those who spent the most time in sedentary work had a risk of distal colon cancer that was twice that of those who spent the most time in a job requiring light activity. Even a high level of vigorous recreational physical activity did not modify the effect of sedentary work," they said.

"The findings have occupational health implications, given that advances in technology have led to increasing amounts of sedentary behaviour at work," they warned.

Sitting down on the job is thought to lead to increased blood sugar levels and damage insulin production, both of which have been linked with the development of bowel cancer.

It could also be that it leads to inflammation deep inside the body, another known risk factor for tumours, the researchers said.

The findings are published in the American Journal of Epidemiology .

30 Tips for Perfect Health

2011-04-06T04:26:00.000-07:00

Drink eight glasses of water a day.
Start the day with a glass of warm water and a dash of lime.
Include two vegetables and one fruit in every meal. Include high fiber foods plenty of fruits, vegetables and grains in planning your diet.
Include one green vegetable and one yellow vegetable in every meal.
Begin each meal with a raw vegetable salad.
Make a light snack of assorted sprouts.
Use only fresh vegetables and meals, and not the leftovers and refrigerated.
Once a week have only fresh fruits until noon and make lunch the first meal of the day.
Go on a juice fast for a day. Start with vegetable juice, and sip fruit for lunch and dinner.
Kick the old coffee habit and avoid beverages like soda, coffee, colas and so on. Have a glass of fresh fruit juice instead.
Cut out all deep-fried foods and high sugar products like soft drinks, ice-cream, candy and cookies from your diet.

For more information view at Clinnovo Health News

How to deal with Work Stress?

2011-03-28T03:52:00.001-07:00

In today’s highly competitive world, almost everyone has been related to different types of stress; may be one form or the other. Almost every working person or a job holder has associated or complaining of work stress.

Stress in any form is not at all good for a person. In a worst side, it can cause health problems and tensions at home and performance issues at work. Psychologists and counselors advise that employees should identify the cause of their stress and tackle it head on. But often, work stress is a combination of factors. In that case, it is very important to improve the ability to cope with stress.

Some of such tips are as follows:

• Mini – breaks: Continuous working without a break affects in a long run as our mind cannot function efficiently non-stop. It is advisable to take 3 to 5 minutes break every 1 or 2 hours.

• Hobby and a friends’ help: Try and squeeze in a 10- to 15-minute break once every three hours and use that time to pursue activities that give you pleasure. If you can’t afford to get away from your desk, try listening to soothing music.

• The right foods: When we are stressed out, some of us tend to eat more. Do yourself a favor by keeping some healthy snacks around. These could include dried fruits, peanuts, cut-up carrots and cucumbers.

• Nice surroundings: Having a desk or a cubicle is almost like at home during the work day. Try and keep the work-space tidy. Try adding a personal touch to the workplace, like a family photo –something which reminds you what all the hard work is for.

• Time Management: Learn to prioritize your work and do the planning accordingly. You can come to work 30 minutes before everyone else and use that quite time for thinking and planning for the day. Stay late at office once in a while if you need to but don’t carry the pending work.

• Deep breathing: Sometimes when we are seriously stressed out, we are so focused on our work that our breathing becomes shallow. Take a minute to breathe deeply a few times and you will feel relaxed almost immediately.

• Exercise: Exercise can burn off the excess energy created during the stress build-up, thereby easing the tension. So make it a point to exercise often, even if it’s for a short period of time. It makes one feel happy because exercise releases the feel-good hormones.

• Better Lifestyle Choices: Individuals should make lifestyle choices which make them physically fit, which in turn, helps them cope with stress better. Get adequate hours of sleep which is something that people these days don’t really get.

Simple Blood Test Detects Early Emphysema in Smokers

2011-03-14T03:20:00.000-07:00

Researchers Say the Test, Which Measures Destruction of Lung Air Sacs, Could Help Prevent Progression of the Common, and Fatal, Lung Disease

During a regular annual physical exam, blood is usually drawn to check the health of a person's heart, kidneys and liver. Now, researchers at NewYork-Presbyterian Hospital/Weill Cornell Medical Center say a blood test that detects the early development of emphysema -- well before symptoms occur -- may someday also be offered.

American Journal of Respiratory and Critical Care Medicine, the researchers say that because most cases of emphysema are caused by smoking, the test they are developing can warn smokers about impending development of the untreatable disease which is currently a major cause of disability and death in the U.S.

Not all smokers develop emphysema, but those who find out they are at risk will be motivated to quit to halt progression of the disease, says the study's lead investigator, Dr. Ronald G. Crystal, chairman and professor of genetic medicine and the Bruce Webster Professor of Internal Medicine at Weill Cornell Medical College and chief of the Division of Pulmonary and Critical Care Medicine at NewYork-Presbyterian Hospital/Weill Cornell Medical Center.

"We know, from other studies, that smokers who learn from objective evidence that their health is in danger are much more likely to quit," he says. "That is the only thing that will help them avoid this deadly disorder."

Emphysema and chronic bronchitis are the twin disorders that make up chronic obstructive pulmonary disease (COPD), which is now the fourth leading cause of death in Americans. Given the aging population, COPD is soon expected to move up to third in mortality prevalence, Dr. Crystal says.

The new test measures particles that are shed by tiny blood vessels known as capillaries that surround air sacs (alveoli) in lungs. These particles are debris shed by ongoing injury to the air sacs -- damage that eventually results in devastation of the sacs and the "Swiss cheese" appearance of the lungs. The alveoli are where critical gas exchanges occur: blood in the capillaries brings carbon dioxide from the rest of the body for release into the air sacs, and the oxygen in the sacs (taken in from breathing) is taken up by the blood and transported to the rest of the body.

As the sacs are destroyed, people develop shortness of breath because they cannot take in enough oxygen to feed the body and eventually cannot remove carbon dioxide from the blood.

Dr. Crystal and his colleagues reasoned that as capillaries surrounding the air sacs are being injured, the debris would be carried out by the blood supply and could potentially be quantified as a disease biomarker. So they began to look for evidence of what they called endothelial microparticles (EMP).

"Our blood vessels are always being replenished, so we all have some level of EMPs in our blood," he says. "What we are looking for are elevated levels of EMPs. For smokers, this is the equivalent of a smoke detector sounding its alarm; elevated levels of EMPs suggest their air sacs are being injured and it is time to act."

To do this, the researchers enrolled three groups of people -- healthy nonsmokers, healthy smokers, and smokers with early evidence of lung destruction. Study participants had their medical histories taken, and to gauge lung function in these participants, all underwent two pulmonary function tests. One is spirometry, which measures the volume and speed of air as it is inhaled and exhaled from the lungs. The other, known as DLCO, is the only lung function test available today that can detect emphysema in patients. It uses a machine that measures the ability of gases to diffuse across the alveolar-capillary membrane.

The researchers found a 95 percent positive correlation between elevated EMPs in the blood and an abnormal DLCO test result, meaning that it detected nearly all verified cases of early emphysema in participants.

Two other independent groups of participants were then given the same group of tests -- spirometry, DLCO and the EMP blood test -- and, once again, a positive EMP finding correlated with an abnormal DLCO 95 percent of the time. Differences in the spirometry findings had no bearing on results of DLCO or EMP.

DLCO, which must be administered by a pulmonologist, is most often used to confirm a suspicion of emphysema, Dr. Crystal says. By contrast, the EMP blood test is designed to be a simple, low-cost screening tool that can pick up development of emphysema in individuals who show no signs of the disorder.

"We need a blood test that can be administered to the 20 percent of American adults who smoke as well as nonsmokers exposed to secondhand smoke -- all who may not understand their risk of developing this progressive lung disease," says Dr. Crystal.

The researchers are conducting further studies of the EMP test in larger groups of participants in order to validate these initial findings.

For more info Visit, www.nyp.org and weill.cornell.edu

Cereal with milk best way to start the day

2011-03-06T22:30:00.000-08:00

A new study has revealed that the healthiest breakfast choice is cereal with milk.

According to the research, breakfast is the key to a healthy lifestyle determining the quality of your whole day's nutrition.

And the best way to start the morning is with a simple bowl of cereal, as it makes people less likely to turn to fatty, sugary food through the rest of the day.

The study, by nutritionist Sigrid Gibson, and published in the BNF Nutrition Bulletin, revealed that cereal is a good source of calcium and numerous other key nutrients, such as fibre, protein and carbohydrate.

The research team analysed 12,068 food records from the National Diet and Nutrition Survey, which interviewed Britons aged from 19 to 64.

The results showed that one in five adults ate no solid food for breakfast, one third chose cereal and 45 percent enjoyed a non-cereal breakfast. The most popular item was tea or coffee, taken on 84 percent of breakfast occasions.

Milk was consumed with 82 per cent of breakfasts, followed by cereal (39 percent), bread (33 percent) and fruit (14 percent).

Women were less likely than men to choose bread, sausage, bacon or eggs and more likely to have fruit instead.

The study found that eating breakfast was associated with a lower fat and higher carbohydrate intake over 24 hours compared with skipping breakfast.

But this was mainly attributable to cereal-based breakfasts as non-cereal meals were associated with a higher intake of saturated fatty acid and lower protein intakes.

"This provides yet more evidence of the importance of eating breakfast and shows the value of making wise choices," a newspaper quoted Newcastle University's nutrition professor Chris Seal, a member of The Breakfast Panel which commissioned the study, as saying.

"People who eat breakfast cereal generally eat less fat, saturated fat and sugar than those who do not and have better intakes of protein and important micro-nutrients, such as iron, vitamins and calcium."

High-sugar diets increase heart risk

2011-01-11T03:36:00.001-08:00

Teenagers who consume high sugar foods in their diets may be at an increased risk of heart disease later in life, says a new study.

The study showed that teens who consume elevated amounts of added sugars in drinks and foods are more likely to have poor cholesterol and triglyceride profiles, making them susceptible to heart diseases later.

And overweight or obese teens with the highest levels of added sugar intake had increased signs of insulin resistance.

"Adolescents are eating 20 per cent of their daily calories in sugars that provide few if any other nutrients," said Jean Welsh, at Emory University School of Medicine.

2,157 teenagers (ages 12 to 18) were studied; results found that the average daily consumption of added sugars was 119 grams (28.3 tsp. or 476 calories), accounting for 21.4 per cent of their total energy.

Teenagers with the highest levels of added sugar consumption at more than 30 per cent of total energy had 49.5 milligrams/deciliter (mg/dL) compared to 54 mg/dL of HDL levels in those with the lowest levels of added sugar consumption — a 9 per cent difference.

Two days of dietary data were used among a subsample of 646 adolescents and the key findings remained consistent:

Those with higher intake of added sugar had higher LDL levels of 94.3 mg/dL compared to 86.7 in those with the lowest levels, a 9 per cent difference.

Triglyceride levels in those with the highest consumption were 79 mg/dL compared to 71.7 mg/dL among the lowest, a 10 per cent difference.

The study is published in the Jan. 10 online issue of the journal Circulation .

Organ donations in India can get a new life through better laws

2010-11-29T03:01:00.000-08:00

Inadequate laws for organ donation in India and lack of knowledge about what to do to donate one’s body parts after death, keep even supportive people from making a legally binding commitment.

For instance, few people know that they can mention it in their wills that their body parts such as kidneys, liver and eyes should be donated after death.

Experts say making it mandatory for all people to express a choice in the matter of organ donation, would increase donations and go a long way towards meeting the shortage of organs for transplant.

With the world celebrating the Sixth (India’s first) International Organ Donation Day on November 28, it may be educative to examine what other countries have done to promote organ donation.

Many countries have adopted a ‘presumed consent’ policy and have passed laws for its implementation. Under this policy, the state presumes that a deceased citizen has said yes to organ donation, unless he has opted out by mentioning this in a legally accepted document.

Dr Sunil Shroff, head of the department of urology and renal transplantation at Sri Ramachandra Medical College and Research Institute in Chennai, said that under ‘presumed consent’ law, the consent of family members is not required. In the event of a person’s death, his/her organs can be retrieved without delay.

The ‘presumed consent’ law was first passed in 1989 by Spain which, till then, had one of the lowest organ donation rates in the world. But thanks to the law, it now has the best organ procurement programme in the world.

Today, Spain has 34 per million person donation rate, despite the fact that it has one of the lowest incidence of road mishaps in the European Union. In contrast, India has just 0.1 per million person donation rate.

The ‘presumed consent’ law now exists in Belgium, Austria, Finland, France, Norway, Spain and Singapore and UK, too, may pass the law soon. Dr HL Trivedi of the Institute of Kidney Disease and Research Centre (IKDRC), Ahmedabad, said the law had led to a dramatic increase in donations in these countries.

"The law has, to a large extent, helped these nations overcome their shortage of organs for donation," Trivedi said.

Dr Shroff, however, said that legislation of a 'presumed consent' law is unlikely to be accepted in India "India has not yet reached that level of awareness that makes organ donation from cadavers a routine matter," he said. "Hence such a law would not help us."

Some other countries, however, have made it mandatory for their citizens to make a choice whether or not they wanted their organs to be donated.

The 'mandatory choice' legislation has been in place in Sweden and Denmark since 1996. Because of this law, Sweden's potential national donor registry has swelled by 6 lakh and Denmark's has increased by 1.5 lakh.

Medical experts are of the view that India, too, should make it mandatory for citizens to declare their choice regarding donation of their organs for transplantation. This can be done by registering with a national body or expressing a choice during issue of important documents such as driving license or national identity card or passport, experts said.

They, however, added that even for 'mandatory declaration' to succeed, there is an urgent need to raise the level of awareness of organ donation in this country.

openings with Ascenders for SAS programmer

2010-11-25T02:40:00.001-08:00

Summary
Experience: 2 - 3 Years
Location:Bengaluru/Bangalore
Compensation:Rupees 4,00,000 - 5,00,000
Education:UG - Any Graduate - Any Specialization
PG - Post Graduation Not Required
Industry Type:Pharma/ Biotech/Clinical Research
Role:Clinical Research Associate/Scientist
Functional Area:Healthcare, Medical, R&D
Posted Date:25 Nov
Desired Candidate Profile
• Has basic understanding of Statistical principles and can understand with some guidance the statistical analysis principles of the SAP.
• Has good understanding of 21 CFR-Part 11 and GCP and GPP principles.
Job Description
• At least 2-3 years SAS programming experience in the Clinical Domain
• Can write programs related to Clinical Trial Analysis as per SAP independently or with very little guidance ( Derived Dataset Programming, TFL programming)
Keywords: sas programmer
Company Profile
-
Contact Details
Company Name:Ascenders
Website:Not Mentioned
Executive Name:Naina Khade
Address:Not Mentioned
Email Address:jobs@ascenders.co.in
Telephone:022-25623134

opening for Sr. SAS programmer @ Banglore

2010-11-25T02:35:00.000-08:00

Summary
Experience: 4 - 6 Years
Location:Bengaluru/Bangalore
Compensation:Rupees 5,00,000 - 8,00,000
Education:UG - Any Graduate - Any Specialization
PG - Post Graduation Not Required
Industry Type:Pharma/ Biotech/Clinical Research
Role:Clinical Research Associate/Scientist
Functional Area:Healthcare, Medical, R&D
Posted Date:25 Nov
Desired Candidate Profile
• Has moderate level understanding of Statistical principles and can understand with little guidance the statistical analysis principles of the SAP.
good understanding of 21 CFR-Part 11 and GCP and GPP principles
• Has good
Job Description
• At least 4-5 years SAS programming experience in the Clinical Domain
• Can write programs related to Clinical Trial Analysis as per SAP independently ( Derived Dataset Programming, TFL programming, Exploratory Analysis Programming)
Keywords: sas programmer
Company Profile
-
Contact Details
Company Name:Ascenders
Website:Not Mentioned
Executive Name:Naina Khade
Address:Not Mentioned
Email Address:jobs@ascenders.co.in
Telephone:022-25623134

Opening with Icon for SAS programmer

2010-11-25T02:29:00.000-08:00

Looking for an experienced SAS Programmer/ SAS Lead with good knowledge
B.Sc (Masters Preferred ) in one of the following fields: Computer Science, Statistics, Mathematics, or relevant science with experience in the Pharmaceutical Industry.
Qualifications:
At least 0- 2 years experience of processing clinical trial data using SAS. At least 0- 2 years of management experience preferably associated within a programming environment and/or with formal drug submissions to regulatory agencies
Sound knowledge of computer hardware, software, and data processing techniques.
Strong skills in project management including time management, planning, problem solving, ability to interface with all levels and different cultures, both internally and externally are required.

Required skills include:
Proficient programming skills in SAS; Sound knowledge of the Software Development Life Cycle and its application in a R D environment; Ability to critically review data; Good oral and written communication skills; Good interpersonal skills and team player.

Kindly revert back with the following details.
Current CTC, Expected CTC, Total Experience, Notice Period.

Neil
Nilamadhab.Mahapatra@iconplc.com
044 4390 2958
ICON Clinical Research India Pvt Ltd
Url: www.iconclinical.com

opening with Tata Consultancy Services for Clinical Data Management.

2010-11-25T02:25:00.000-08:00

This is for a Team Lead position.

Candidates need to be flexible with any shift incl night shifts.

 Academic Qualification :

o Graduate/Postgraduate in Science

Experience:

o Minimum 4 years experience with 2+ years in CDM with atleast 6 months in leading a project
o Solid experience and understanding of ICH GCP principles, clinical drug development process, organizational, communication and data management skills

 Others:

o Capability to lead by motivation and example
o Ability to prioritize schedule and organize
o Knowledge of Oracle, PL/SQL is required.
o Knowledge of SAS is required.
o Excellent interpersonal and communication skills
o General knowledge of Clinical Trials and Pharmaceutical Industry

If interested revert asap.

Sharon
Recruitment Officer
Tel : 022-65904515
sharon@globalsearchservices.com
GlobalSearch Services
101,Shubam Palace, Sector 15, Kopar Khairne,Navi Mumbai - 400709

Sibutramine- an Anti-obese drug suspended by DCGI

2010-11-25T02:23:00.000-08:00

The Drugs Controller General of India (DCGI) on Friday ordered the “suspension” of the manufacture and import of anti-obesity drug Sibutramine after the medicine showed serious side effects, including heart attack, among some users. The DCGI also recommended to the Ministry of Health and Family Welfare a total ban on the sale of the drug.

It proposes the setting up of various committees to oversee the safety of drugs and also the feasibility of introducing new drugs in India.

The suspension order was issued under Section 26 (A) of Drugs and Cosmetic Act, with immediate effect, with the DCGI also seeking a total prohibition on its manufacture and sale in the open market. The ban has to be formally notified by the Health Ministry on the recommendation of the DCGI.

The decision was taken following recommendations of an expert committee comprising pharmacologist Y.K. Gupta (All-India Institute of Medical Sciences), endocrinologist A.C. Ammini (AIIMS) and S.D. Seth (Institute of Clinical Research) and Anoop Misra (Fortis Hospital).

Orlistate is now the only drug in the market for obesity-management and weight loss, though many new drugs are expected to be in the market shortly.

The decision to ban Sibutramine, sold under different brand names, was taken after studies found it increased the risk of heart attack, stroke and death. The drug has already been banned in the United States, Canada and Australia and was withdrawn in China on Tuesday. The European Medicine Agency (EMA) too has recommended complete withdrawal of this drug.

The preliminary reports of the “scout trials” on Sibutramine showed increase in heart rate and blood pressure among users. This was further confirmed in the final finding of the trial, promoting the government to take prohibitory action.

This is the third drug relating to diabetes and obesity that has been banned in India in the last one-and-half years.

Last month, the government banned the import and manufacture Rosiglitazone, an anti-diabetic drug. Rosiglitazone is already banned in Europe after users experienced serious side effects, including cardiovascular events and adverse effects on lipid profile.

Prior to that, anti-obesity pill Rimonabant was banned in March 2009 after it was found to cause depression and suicidal tendencies.

One of the most commonly prescribed medicines for weight loss and obesity management, Sibutramine has been available in India since 1999. It is manufactured and marketed by over 20 generic companies under various brand names.

Sr. Product Development Manager - Food / For Bira Life Sciences/ Mumba

2010-11-22T00:50:00.000-08:00

Sr. Product Development Manager - Food / For Bira Life Sciences/ Mumba
Posted by: BIrla Life Sciences - A Yash Birla Group
Posted date: 18-Nov
Job Description:Bench top/ Pilot Plant development/ Formulation of Food Products Prdct Testing/ Shelf Life testing. Scale up &Commercialization of prdts developed 3rd party vendor Sensory Evaluation/ Ingredient sourcing/development of the new products.PFA Foods App

Desired Candidate ProfileFood formulation/culinary ability/Food Testing skills- chemical, physical and analytical/ PFA Foods Knowledge/Sensory Evaluation/ Knowledge of food manufacturing processes, GMP s HACCP. Prdt R&D from concept to finished product (commercial).

Experience Required: 8 - 12 Years

Education Required: UG - Any Graduate - Any Specialization PG - Any PG Course - Any Specialization
More....http://www.spanjobs.com/india/jobs/retail-merchandising-jobs/mumbai-jobs/sr-product-development-manager-food-for-bira-life-sciences-mumba/1402663?action=search&offset=585&utm_source=Indeed&utm_medium=organic&utm_campaign=Indeed

Bio Pharma Industry Associate Job - ScienceCentre.in

2010-11-18T08:32:00.000-08:00

Science Centre has been set up by the Clinnovo Research Labs, Hyderabad, as its subsidiary with the aim of bridging the gap between the biomedical sciences education and professional career in industry and academic centers of excellence.

Science Centre announces BIOPHARMA INDUSTRY ASSOCIATE positions for entry level and senior professionals in the clinical/biopharmaceutical arena.

The one year associate position will involve training from experts and working as associates in ongoing clinical,imaging and informatic projects. At the end of one year candidates will have the possibility of continue their positions at Science Centre, subject to their work performance during the one year period.

Associates will be rotated among different departments and will work on projects involving international collaborations and MNC sponsors.

For More check
http://sciencecentre.in/?cont=industry-associate

Clinical Data Associate

2010-03-02T04:51:00.000-08:00

Job Description

Clinical Data Associates required for our client, a globally renowned CRO. Placement at Trivandrum. Immediate Requirement.

* You will undergo training for a period of 6 months in Chennai.
* You will also update/correct/review data in the clinical databases based on resolved data queries.
* You will compile and distribute necessary study documentation and maintain study files in accordance with all applicable procedures. you will assist with the testing of data entry screens and the preparation of relevant testing documentation.
* You will also generate, review for accuracy and distribute status reports as requested.

Desired Candidate Profile

* Good Oral and Written Communication Skill
* Quick Learning Curve
* Good Team Player

Experience 0 - 1 Years
Location : Trivandrum
Education : M.Sc Bio-Chemistry, Biology, Botany, Home science, Microbiology,
Company Name : Sai's BioSciences Research Institute
Website : http://www.SBRIonline.info
Executive Name: Ms. Pradeepa
Email Address : cdm@SBRIonline.info
Telephone : 91-44-42113881

SAS Analyst

2010-02-18T12:03:00.000-08:00

Job Description

Data extraction, cleaning, transformation and reporting using SAS and Excel . Use SAS procedures like proc summary, proc tabulate, proc means, proc univariate, proc ANOVA and excel pivot for marketing campaign.

Desired Candidate Profile

Applied knowledge on Logistic, Linear regression, segmentation. Communicating business results with clients and peers.

Experience : 1 - 3 Years
Location : Hyderabad / Secunderabad
Company Name : Client of Emilestones India
Executive Name: Nanda
Email id : nilotpala@emilestones.net
Telephone : 08041714296

Drug Safety Associate

2010-02-10T08:33:00.000-08:00

Role Responsibility

You will be responsible for monitoring and tracking Serious Adverse Events, serious and non serious drug adverse reactions and other medically related project information. You will ensure that all ICON, Sponsor and Regulatory timelines are met for the processing ad recording of safety information.
Additional Responsibilities:

• Document and process serious adverse event reports within ICON, regulatory authorities and sponsor regulations and timeframes

• Provide input for and review relevant safety tracking systems fro accuracy and quality

• Perform safety review of clinical data (case report forms) and patient labs

• Assist medical monitor in documentation and processing routine exception and re-screen approvals

• Liaise with investigational sites and reporters on safety related issues

• Serve as medical resource to investigational sites and ICON personnel on safety related issues

• Perform safety related training for extra-department ICON staff

Experience and Qualification

With a science degree, pharmacy or nursing background you will have a minimum of 6 months to 1 years experience in a drug safety environment. You will possess excellent verbal and written communication skills and must be fluent in English. This will be combined with a good knowledge of medical terminology.
In addition you will also require:

•Good basic computer skills in MS office applications and data base use

•Produce high quality work and be detail orientated

•Be able to prioritise your work to meet required deadline

•Be willing to travel up to 10%.

Company Name : Icon Clinical Research India Private Limited
Experience : 1 - 3 Years
Executive Name: Neil
Email Address : Nilamadhab.Mahapatra@iconplc.com
Telephone : 04443902958
Department : Medical Safety
Location : Chennai

Clinical Analyst

2010-02-01T00:56:00.000-08:00

Job Description

To do a research analysis on the clinical data.To usae the tools of analysis for the data analysis.

Desired Candidate Profile

A science graduate with good subject knowledge and with good exposure in clinical process.

Experience : 0 - 2 Years
Location : Chennai
Compensation: Rupees 1,75,000 - 2,75,000
Company Name: Pepo Technologies
Executive Name: Poornima

Address :
Pepo Technologies
7th main road,
Annanagar,chennai-40
CHENNAI,Tamilnadu,India 600040

Email Address:pepotechnologies@yahoo.com

Telephone: 44-91-9710905599

Training & Placement Officer (TPO)

2010-01-08T09:03:00.000-08:00

Job Description

The TPO will be responsible for establishing and maintaining relations with the industry for appropriate Training & Placement of the students.
Also, with academic institutions for Institute promotion.
Will be required to make Power Point presentations etc.

Desired Candidate Profile

Candidate should have a pleasant personality, good communication and computer skills.
Experience of TPO is essential.
Should be willing to undertake the necessary travel.

Experience:

1 - 6 Years

Location:

Chandigarh

Company Name:

ANOVUS INSTITUTE OF CLINICAL RESEARCH

Website:

http://www.anovus.net

Executive Name:

Dr Dharinder Tayal

Address:

ANOVUS

PLOT NO. 28-29

SEC 24-C

CHANDIGARH

CHANDIGARH,Chandigarh,India 160001

Email Address:

dharinder.tayal@anovus.net,tayal1@yahoo.com

Telephone:

9814000720

Clinical Research Analyst

2010-01-02T04:44:00.000-08:00

Job Description
1) screening of patients and developing referral mapping of patients
2) Schedule patient visits
3) Proper documentation and reporting according to required standards
4) Efficient patient follow-up
5) Study closure and Submission of report

Experience : 0 - 5 Years
Location : Bengaluru/Bangalore
Executive Name: Reema
Reference ID : WIN097
Company Name:Winpro Technologies
Direct WALK-IN

Venue: From Monday to Saturday in-between 10am to 6pm.

Add: WINPRO TECHNOLOGIES, # 25, 2ND Floor, 4th Cross, Opp to Swarna Bharti Co-Operative Bank, Jayanagar 7th Block, K.R. Road, Bangalore-82.

Cont # 080-32020520/ 9241763009.

Website: http://www.winprotechnologies.co.in

Clinical Research- Assistant

2009-12-22T08:56:00.000-08:00

Job Description

Data Management, validation of CRFs, CRF designing, Discrepency checking, updation & varification of DCF, Interaction with Client, independently handling of Clinical Trial Project., assisting Consultant Clinical Research in other research job.

Company Profile

1st NABH with NABL, CAP & ISO 9001-2000,14001, OHSAS 18001 certified primier cardiac care centre. This State of Art, internationally reputed hospital belongs to C.K.Birla group.

Experience : 1 - 3 Years

Location : Kolkata

Company Name: B.M.BIRLA HEART RESEARCH CENTRE

Executive Name: Ramesh Lall/Sounak Sengupta

Address

B M Birla heart research centre
1/1, National Library Avenue, Kolkata - 700054
KOLKATA,West Bengal,India 700054

Email Address : hrd.bmbhrc@bmbhrc.com

Telephone : 33-91-30403035

Website : http://www.birlaheart.org

Istodax - Recently approved Drug by FDA

2009-12-17T08:58:00.000-08:00

Generic Name : romidepsin
Date of Approval: November 5, 2009
Company : Gloucester Pharmaceuticals

The U.S. Food and Drug Administration (FDA) approved Istodax (romidepsin) for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy.

Istodax is a prescription medicine used to treat people with a type of cancer called cutaneous T-cell lymphoma (CTCL) after at least one other type of medicine by mouth or injection has been tried. It is not known if Istodax is safe and effective in children under 18 years of age.

Link: http://www.drugs.com/istodax.html

Pennsaid - Recently Approved Drug by FDA

2009-12-10T01:01:00.000-08:00

Generic Name: diclofenac sodium topical solution
Date of Approval: November 4, 2009
Company: Nuvo Research Inc.

The U.S. Food and Drug Administration (FDA) has approved Pennsaid Topical Solution (diclofenac sodium topical solution) for the treatment of the signs and symptoms of osteoarthritis of the knee.
Pennsaid Topical Solution is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). It works by reducing hormones that cause inflammation and pain in the body.

Pennsaid is used to treat the signs and symptoms of osteoarthritis of the knee(s).

Link: http://www.drugs.com/pennsaid.html

Clinical Research Associate

2009-12-07T06:05:00.000-08:00

Job Description

Planning and managing the activities according to top management strategic decision making

• Over see and do all the activities as follows

1. Input to protocol from DM perspective

2. Design database as per the protocol

3. Manage data entry/ verification/ Edit/ Cleaning

4. Retrieve data for analysis

5. Review CSR frm DM perspective

• Keep all the documents properly in data management master file by study wise respectively.

Desired Candidate Profile
Planning and managing the activities according to top management strategic decision making

• Over see and do all the activities as follows
• Keep all the documents properly in data management master file by study wise respectively.

Experience : 1 - 2 Years
Location : Mumbai
Compensation: Rupees 1,50,000 - 2,50,000
Company Name: wockhardt limited
Website : http://www.wockhardt.com

Lysteda - Recently approved Drug by FDA

2009-11-28T09:36:00.000-08:00

Generic Name : tranexamic acid
Date of Approval : November 13, 2009
Company : Xanodyne Pharmaceuticals, Inc.

The U.S. Food and Drug Administration (FDA) has approved Lysteda (tranexamic acid) for treatment of women suffering from cyclic heavy menstrual bleeding (HMB), also known as menorrhagia.

Lysteda is a prescription medicine used to treat your heavy monthly period (menstruation) when your bleeding gets in the way of social, leisure and physical activities. Lysteda does not contain any hormones. On average, Lysteda has been shown to lower the amount of blood lost during your monthly period by about one-third, but it is not meant to stop your period. Lysteda is taken only during your period and is not meant to treat pre-menstrual symptoms.

Link: http://www.drugs.com/lysteda.html

Infonetica’s Research Ethics Database (RED) - Introduction

2009-11-25T05:40:00.000-08:00

RED was originally developed by Infonetica Research Systems for NRES (http://www.nres.npsa.nhs.uk/) - the National Research Ethics Service in the UK. It has now been licensed and is available worldwide to Institutional Review Boards (IRBs) and Ethics Committees. RED provides administrative support for IRB/ethics committee administrators, and regional and national management information. It is available as a single, multi-site or national system, providing each administrator with their own unique view of their IRB/committee.

RED is a complete, web-based solution for research ethics application processing, handling both committee administrator tasks and management information. When used in conjunction with the Integrated Online Form Framework, the system provides an ‘end to end’ solution that also handles the information requirements of the applicant.

RED allows administrators to manage the application process to an IRB/ethics committee. It constantly monitors the elapsed time on all projects simultaneously, warning of studies that are in danger of over running the contracted timescales. RED takes a stepwise approach to managing every part of the process taking into account, provisional decisions, rejections, approvals, amendments and site specific assessments.

Nationally RED can provide information on every IRB/committee and comes with a powerful suite of Management Reports It gives managers important real time information on any studies that are in danger of breaching the timescales set by the EU directive – allowing managers to intervene early on to avoid any breaches before they happen. The report suite also allows trend analysis, giving the ability for long-term capacity planning in the ethics committee network.

Link: http://www.infonetica.net/content.aspx?id=3&type=content

ReDA 2 - the proven R&D management solution

2009-11-19T09:38:00.001-08:00

ReDA 2 is the web-based dedicated solution to assist in the portfolio management of research projects and clinical trials. Developed in conjunction with the NHS, ReDA 2 was launched in the UK in June 2003 and is now in use at over seventy leading Health and Academic institutions.

Features:

• Comprehensive project and investigator data fields.
• Online project document storage and change tracking
• Data import and archiving of online ethics forms.
• Email list management and email recording.
• Remote site read and read/write access.
• Data export to Word or Excel.
• Real time reporting features with statistics and graphing.
• Custom field creation for localised needs.

Link: http://www.infonetica.net/content.aspx?id=5&type=content

eCRF Developer

2009-11-12T09:36:00.000-08:00

Job Description

1. Develop the eCRF layout and the database corresponding to the eCRFs to hold the data from the EDC system.
2. Maintain and update the eCRF application and its components as required for protocol amendments or required metadata updates.
3. Create, test and maintain trial specific plausibility and consistency checks.
4. Create the data extract specifications.
5. Provide the data transfer specifications, test transfers and load third party data.
6. Develop database specifications and provide support for outsourced trials.
7. Develop study specific monitoring reports.
8. Program basic SQL queries to resolve problems with the eCRF applications.
9. Support reporting requirements using SQL and SAS.
10. Create and file trial documentation

Desired Profile

University or college degree in life science, computer science, pharmacy, nursing or equivalent relevant degree. • 1-3 years working experience, with 1-2 years experience in clinical programming, set up of clinical databases and CRF design, gained in pharmaceutical industry or CRO.

Experience : 1 - 3 Years
Location : Hyderabad / Secunderabad
Contact : Novartis Healthcare Pvt Ltd
Website : http://www.novartis.com

Clinical Research Associate

2009-11-10T07:59:00.000-08:00

Job Description
1) Identify Investigator database. Procure the competitive information for the same
2) To help in preparing the essential documents
3) Conducts the essential documents
4) Initiate, does monitoring
5) Helps in preparation of clinical study report
6) Investigators
7) Ethics Committee
8) Finance
9) Regulatory

Desired Candidate Profile

Use of Computer, Knowledge of ICH-GCP, Traveler and Eager to learn.

Experience : 0 - 1 Years
Location : Mumbai, Mumbai Suburbs, Navi Mumbai
Company Name: wockhardt limited

ClinPhone® Drug Accountability

2009-11-06T06:20:00.000-08:00

ClinPhone® Drug Accountability is a cutting-edge, web-based solution that enables centralized management of the entire clinical trial supply chain. When combined with Trial Supply Management, it allows sponsors, sites and depots to perform drug accountability, reconciliation, returns and destruction activities. ClinPhone Drug Accountability is the first application of its kind providing full electronic management and visibility of the clinical trial supply chain, complete with end-to-end documentation detailing the lifecycle of individual investigational products.

Key Features

* Management and tracking of entire medication supply chain from issue to destruction

* Full integrated reporting of drug accountability, reconciliation, returns and destruction

* Integration with ClinPhone Trial Supply Management databases

* Offline monitoring functionality

Link: http://www.perceptive.com/ClinPhone-RTSM/Drug-Accountability.html

Clinical Data Coordinator

2009-11-04T03:30:00.000-08:00

Job Description

To handle datasets of clinical data from Biometric databases status and efficacy datasets project specific macros and formats. Summary tables, listings and graphs as per statistical analysis plan.

Desired Candidate Profile

Working knowledge of the procedures of clinical programming and data management.Proficient in SAS,Statistical Skills,Developing SAS Macros,Knowledge on understanding Statistical Analysis Plan.

Experience : 0 - 2 Years

Location : Bengaluru/Bangalore, Chennai, Hyderabad / Secunderabad

Contact Details

Company Name : Hify Call Zone

Website : http://www.hifycallzone.com

Executive Name: Sathya

Address : Hify Call Zone

AG 43,3rd Street,7th main road,

Annanagar Near Shanthi Colony Bus Stop

CHENNAI,Tamilnadu,India 600040

Telephone:

91-44-9841311813

Reference ID:

cdc-01

Patient Recruitment Technology

2009-10-31T03:22:00.000-07:00

Perceptive's Patient Recruitment technology is an innovative solution to screen candidates and to qualify appropriate subjects for a clinical trial. Using automated telephone interviews and/or web screeners to qualify candidates responding to media advertising for a specific clinical trial, our solution represents a highly efficient and cost-effective solution to drive trial recruitment. It is designed to provide a real-time picture of the qualification process—providing you with the information vital in optimizing your ongoing recruitment campaign and allowing you to make timely decisions regarding your inclusion and exclusion criteria or the opening of new study sites.

Key Features

* Study-specific pre-qualification of clinical trial candidates via web and/or phone
* Complete multinational and multilingual capabilities with no requirement for call center services
* Validated computerized clinical assessments
* Compliant with HIPAA, Data Privacy regulations and registered with UK Data Protection Register

Link: http://www.perceptive.com/ePRO/Patient-Recruitment.html

CLINICAL RESEARCH OFFICER

2009-10-29T06:10:00.000-07:00

Job Description
Writing Research Paper. Medical Content Writing. Active Role In Development Of Cell Therapy. Handling Clinicaltrials. Giving Suggestions & Making Improvemnts In Existing Processes. Should Be Ready To Attend Various Surgical Operations.

Desired Candidate Profile
Writing Research Paper. Medical Content Writing. Active Role In Development Of Cell Therapy. Handling Clinicaltrials. Giving Suggestions & Making Improvemnts In Existing Processes. Should Be Ready To Attend Various Surgical Operations.

Experience : 1 - 2 Years
Location : lONAVALA
Compensation : Rupees 1,00,000 - 3,00,000
Company Name : REGENERATIVE MEDICAL SERVICES PVT. LTD.
Website : http://www.regrow.in
Executive Name : Ms. Trupti Damugade
Email Address : hr@regrow.in,yashs@satyanltd.com

RTSM Reporting Solution

2009-10-28T02:27:00.001-07:00

ClinPhone® RTSM (Randomization and Trial Supply Management) offers powerful reporting functionalities to help you answer key questions through intelligent analysis and presentation of your study’s randomization and trial supply management data. Our easy-to-use solution is designed for optimal performance to ensure rapid and efficient access to study data and metrics. It comes in three modules:

Universal Report Suite - Ready-made, validated reports providing key study performance and trial supplies data suitable for all RTSM users including study directors, CRAs, supplies personnel and site staff

Key Features

* Secure online interactive reports and scheduled reports via email
* Provided for all ClinPhone RTSM studies with additional customization options available
* Key study performance data including study recruitment and supply chain information
* Built-in capabilities to create and export graphs and charts of key study data

Link: http://www.perceptive.com/ClinPhone-RTSM/RTSM-Reporting-Solution.html

ClinPhone® MedSim

2009-10-26T10:17:00.000-07:00

ClinPhone® MedSim is a leading-edge consulting service that enables you to gain a solid understanding of your entire supply chain strategy and allows you to accurately estimate supply requirements for your clinical trials. Our consultants use statistical simulation techniques to predict how medication is distributed and used in your study. By modeling the variability inherent in a clinical trial—such as random subject recruitment—our approach provides robust estimates of your future supply needs. Unlike naïve forward forecasting approaches, our simulations provide valuable information to support effective decision-making. Study teams can rely on our consultants to effectively compare alternative supply strategies, assess associated risks, and estimate desirable supply quantities.

Key Features

* Simulation of clinical supply chain using dozens of real-world factors
* Strategic planning and analysis of complete supply chain methodology
* Calculation of clinical trial supply needs, reducing unnecessary overage
* Exploration of minimum supply requirements to commence study

Link:http://www.perceptive.com/ClinPhone-RTSM/MedSim.html

AgXchange RSM™

2009-10-21T08:52:00.000-07:00

Electronic submission of regulatory data

The agXchange RSM (Regulatory Submissions Module) supports the submission of the EVMPD product data as requested by the EMEA. Initially supporting the submission of EVMPD data, agXchange/RSM can be easily extended to support the electronic submission of other regulatory data including SPL, PIM and eCTD documents, etc.

Predicting the need to support the EVMPD initiative in compliance with the proposed guidelines, Aris Global has released agXchange to support the submission of EVMPD data using an electronic gateway that can be integrated with any source of regulatory product.

Link: http://www.arisglobal.com/products/agxchange_rsm.php

Register™

2009-10-19T10:01:00.000-07:00

Regulatory affairs tracking system

Aris Global believes that when it comes to regulatory affairs, compliance is not simply a document, it's a process that ensures that data is complete, accurate, approved and available to stakeholders and regulatory authorities across each product's entire lifecycle.

End-to-end regulatory tracking software
Central repository for managing global product portfolios
Planning module automates drug registration tracking against global and local project plans
Bridges compliance gap between regulatory and other business functions
Leverages integrated technology and functionality in systems such as SAP, Documentum, and publishing systems

Link: http://www.arisglobal.com/products/register.php

DuraSeal Spine Sealant System

2009-10-14T20:50:00.000-07:00

Product Name : DuraSeal Spine Sealant System
PMA Applicant: Covidien
Address : 101A First Avenue, Waltham, MA 02451
Approval Date : September 4, 2009

The DuraSeal Spine Sealant System is used in spinal surgery and applied over sutures (stitches) to prevent cerebrospinal fluid (CSF) from leaking out of the incision site. The System consists of components to prepare an absorbable sealant (polyethylene glycol hydrogel) and a delivery system (an applicator and spray tips, packaged in a single use kit). The sealant is composed of two solutions (polyethylene glycol (PEG) ester and trilysine amine) referred to as the blue and clear precursor solutions.

When mixed together, the two solutions rapidly combine (in situ polymerization) to form a sealant gel that seals the dura mater. The dura mater is the tough, outermost, fibrous membrane that covers the brain and spinal cord, and lines the inner surface of the skull. The sealant is sprayed or layered onto the sutured incision site. It adheres to the tissue and it is more than 90% water. The blue color helps the surgeon see the sealant, which naturally breaks down and is absorbed within four to eight weeks, enough time to allow for healing.

Link: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm185478.htm

Clinical Research Associate- Delhi

2009-10-13T11:11:00.000-07:00

Job Description

• Monitor the conduct of clinical trials, especially enrollment and quality of data.
• Verify subject safety and site adherence to FDA Regulations and ICH/GCP Guidelines.
•Review CRF, Informed Consent Documents and query language/narratives.
• Conduct Qualification, Initiation, Interim and Closeout monitoring visits.
• Ensure complete and thorough study drug reconciliation.
• Manage monitoring reports, letters, query resolutions.Ensure the integrity of data submitted on CRFs or other data collection, SAE reporting, follow up of SAE's and safety mailing to sites.

Experience : 1 - 3 Years
Location : Delhi/NCR
Compensation : Rupees 2,75,000 - 3,25,000
Company Name : Clinical Trials
Executive Name : Ms.Prachi Mendiratta
Email Address : prachi.mendiratta@lglsi.com

FDA Orders Postmarket Surveillance Studies on Certain Spinal Systems

2009-10-12T05:01:00.000-07:00

FDA to request premarket clinical data for new versions of these devices

The U.S. Food and Drug Administration ordered manufacturers of certain types of pedicle screw systems, called dynamic stabilization systems, to conduct postmarket surveillance studies to collect clinical data on a number of potential safety issues, including fusion rates and frequency of additional surgeries on Oct. 5, 2009.

Dynamic stabilization systems are used in spinal surgery and some are intended to provide stabilizing support to the spinal column during bone fusion. Currently, there is not enough clinical data to determine whether these dynamic stabilization systems provide enough spinal stability to allow for complete spinal fusion, as the system components may loosen, bend, or break over time. If fusion does not occur, a patient’s condition could worsen and possibly require additional surgical procedures.

The FDA is requiring postmarket studies to address these potential risks for systems already on the market. In addition, the FDA is requesting manufacturers with new dynamic stabilization systems or components to submit clinical information for agency review prior to marketing.

The FDA cleared the first dynamic stabilization system component in 1997. The FDA has cleared numerous dynamic stabilization systems or components since then. FDA has only ordered postmarket surveillance studies for the class II dynamic stabilization systems and components, which are intended for bone fusion.

The FDA has required the manufacturers of 16 dynamic stabilization systems or components on the market for spinal fusion to conduct postmarket surveillance studies, which must address the following:

1) The fusion rate for dynamic stabilization systems compared to traditional stabilization systems;
2) The incidence rate, severity, and time course of adverse events for dynamic stabilization systems compared to traditional stabilization systems;
3) The type, incidence rate, and time course of subsequent surgical procedures for dynamic stabilization systems compared to traditional stabilization systems; and
4) The cause of failure for dynamic stabilization systems based on analysis of all reasonable available systems that have been removed from patients, along with any association between the patient’s demographic and clinical data and the device failure.

Link: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm185312.htm

Folotyn (pralatrexate)

2009-10-08T11:50:00.000-07:00

The U.S. Food and Drug Administration has approved Folotyn (pralatrexate), the first treatment for a form of cancer known as Peripheral T-cell Lymphoma (PTCL), an often aggressive type of non-Hodgkins lymphoma.

Folotyn was approved under the FDA's accelerated approval process, which allows earlier approval of drugs that meet unmet medical needs. It is approved for patients who have relapsed, or have not responded well to other forms of chemotherapy.
Lymphoma is a cancer of the lymphatic system, which is part of the immune system. There are many types of lymphoma: one type is called Hodgkin's disease, and the rest are called non-Hodgkin's lymphomas. PTCL involves a type of white blood cell called T-cells. It is a relatively rare disease, occurring in less than 9,500 patients each year in the United States.Folotyn is manufactured by Allos Therapeutics Inc. of Westminster, Colo. Folotyn can harm a fetus. Women should avoid becoming pregnant while being treated with this drug and pregnant women should be informed of the potential risk.

Link: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm183799.htm

Stelara

2009-10-05T01:17:00.000-07:00

On Sept. 25, 2009 The U.S. Food and Drug Administration approved Stelara, a biologic product for adults who have a moderate to severe form of psoriasis.

Plaque psoriasis is an immune system disorder that results in the rapid overproduction of skin cells. About 6 million people in the United States have plaque psoriasis which is characterized by thickened patches of inflamed, red skin, often covered with silvery scales.Since Stelara reduces the immune system’s ability to fight infections, the product poses a risk of infection. Serious infections have been reported in patients receiving the product and some of them have lead to hospitalization. These infections were caused by viruses, fungi, or bacteria that have spread throughout the body. There may also be an increased risk of developing cancer.

Link: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm183851.htm

FDA Launching New Rules to Expand Access to Investigational Drugs

2009-10-01T23:01:00.000-07:00

The U.S. Food and Drug Administration published two new rules to help seriously ill people gain access to investigational drugs when they are not eligible for clinical trials and have exhausted other treatment options.

The rules, which go into effect in mid-October, clarify the procedures, standards and costs of providing investigational drugs as part of a clinical trial or when used outside the scope of a trial.

The FDA also has dedicated a portion of its web site to providing patients and health care providers with information about investigational drugs that have been approved by the FDA or are being given as part of clinical trials.

Link : http://www.centerwatch.com/news-resources/clinical-trials-today/headline-details.aspx?HeadlineID=685

CLINICAL RESEARCH NURSES

2009-10-01T01:37:00.000-07:00

Job Responsibilities

• Patient recruitment & Site staff (Doctor) training.

• Organise & assist Site (Hospital) feasibility, Site selection, Site initiation, Site close out for smoother conduct of Clinical Trials.

• Site (Hospital) set-up in accordance with Research Protocol.

• Ethics committee submission, query resolution and communication.

• Pre-screening of research patient & assistance in Consenting for trials.

• Co ordination of research subject follow-up visits & Management of Clinical trial materials (Including Drug, Documents, etc.)in particular hospitals.

• Identification of any possible Adverse events (AE) / Serious adverse events (SAE).

• Documenting & Reporting SAE’s to Sponsors (Pharma Company / CRO), Ethics Committee in specified timelines.

• Ensure Documentation of all research related data in Source documents; Maintenance & Updation of all Research study documents (CRF, ICF, TMF) in stipulated timelines.

• Coordination of monitoring & Audit Visits from Sponsors (Pharma company / CRO).

• Resolution of data queries from Sponsor.

• Coordination of site close out & Storage of Trial documents as per requirements.

Eligibility : BSc Nursing with 0-2 year Experience.

Company Name : Altree Lab Pvt Ltd

Website : http://www.altreelab.com

Executive Name: Dr.Bob Eapen

Recently apporoved H1N1 Vaccines by U.S FDA

2009-09-28T23:54:00.000-07:00

The U.S. Food and Drug Administration announced on Sept 15, 2009, that it has approved four vaccines against the 2009 H1N1 influenza virus. The vaccines will be distributed nationally after the initial lot become available, which is expected within the next four weeks.

The four vaccines come from CSL Limited, Novartis Vaccines and Diagnostics Limited, Sanofi Pasteur Inc. and MedImmune LLC. One of them is an intranasal vaccine.

As with the seasonal influenza vaccines, the 2009 H1N1 vaccines are being produced in formulations that contain thimerosal, a mercury-containing preservative, and in formulations that do not contain thimerosal.

People with severe or life-threatening allergies to chicken eggs, or to any other substance in the vaccine, should not be vaccinated.

Link: http://www.nlm.nih.gov/medlineplus/news/fullstory_89386.html

http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm181950.htm

Project Physician

2009-09-25T09:28:00.000-07:00

Department : Clinical Development
Position : Project Physician
Qualification: MD, Pharmacology /Phd Biology
Experience : 0- 1 years
Location : Bangalore

Job Description

Prepare and review clinical study documents like protocol, Investigator brochure, informed consent forms, patient dairies etc.
Handle medical queries.
Support feasibility team in the assessment of the feasibility of a project.
Handle safety reports and train CRAs in different therapeutic areas.

Desired Profile

Should have working knowledge of various accepts of clinical trials including the medical, regulatory and operational aspects like ICH GCP, Schedule Y, Biostatistics, etc.
Should have good academic background especially the medical training.
Must have working knowledge of MS Office tools like Word, Excel, Power point, etc.
Should have experience in medical writing (publication if any).
Should have the ability to analyze and infer information especially medical, preclinical, and pharmaceutical.
Should be able to prepare medical manuscript for various purposes.

Link: http://www.clinigeneintl.com/clinigene_careers_job.asp

Bepreve

2009-09-23T22:42:00.000-07:00

Generic Name: bepotastine besilate ophthalmic solution
Date of Approval: September 8, 2009
Company: ISTA Pharmaceuticals, Inc.

The U.S. Food and Drug Administration (FDA) has approved Bepreve (bepotastine besilate ophthalmic solution) 1.5% as a twice-daily prescription eye drop treatment for ocular itching associated with allergic conjunctivitis in patients two years of age and older.

Bepreve (bepotastine besilate ophthalmic solution) 1.5% is a histamine H1 receptor antagonist indicated for the treatment of itching associated with signs and symptoms of allergic conjunctivitis.

Link: http://www.drugs.com/bepreve.html

Metozolv ODT - Recently approved drug

2009-09-23T00:19:00.000-07:00

Generic Name: metoclopramide
Date of Approval: September 4, 2009

Company: Salix Pharmaceuticals, Ltd.

The U.S. Food and Drug Administration (FDA) have granted marketing approval for Metozolv ODT (metoclopramide HCl) 5mg and 10mg orally disintegrating tablets. Metozolv ODT is indicated for the relief of symptoms in adults associated with acute and recurrent diabetic gastroparesis and for the treatment of short-term therapy (4-12 weeks) for adults with symptomatic documented gastroesophageal reflux disease (GERD) who fail to respond to conventional therapy.

Metozolv ODT contains metoclopramide which increases muscle contractions in upper digestive tract. This speeds up the rate at which the stomach empties into the intestines. Metozolv ODT melts on the tongue without the need for water, and offers patients who have trouble swallowing tablets a more convenient option than traditional metoclopramide tablets.

Link: http://www.drugs.com/metozolv-odt.html

Recently Approved Drug

2009-09-22T10:45:00.000-07:00

Intuniv

Generic Name: guanfacine
Date of Approval: September 2, 2009
Company: Shire plc

The US Food and Drug Administration (FDA) have approved Intuniv (guanfacine) Extended Release Tablets for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adolescents aged 6 to 17 years.

Intuniv is a prescription medicine used to treat the symptoms of attention deficit/hyperactivity disorder (ADHD). Intuniv, a once-daily formulation of guanfacine, is the first selective alpha-2A adrenergic receptor agonist approved for the treatment of ADHD. Although the mechanism of action is unknown, Intuniv is thought to directly engage receptors found in the prefrontal cortex - an area of the brain that has been linked in preclinical research to ADHD. Stimulation of the postsynaptic alpha-2A receptors is thought to strengthen working memory, reduce susceptibility to distraction, improve attention regulation, improve behavioral inhibition, and enhance impulse control.

Link: http://www.drugs.com/intuniv.html

East®

2009-09-19T10:31:00.000-07:00

With more adaptive, group sequential and fixed-sample size clinical trial designs than any other commercial software package, East® 5 delivers a host of new features to better guide trial planners through the myriad of design options.

East® is the most widely used clinical trial design software system in use today. East’s methodologies are fully referenced and all designs are highly validated. Hundreds of adaptive and traditional trials worldwide have been designed and implemented using East® by biopharmaceuticals, device companies and research organizations.

Current versions of East® are installed in all the clinical study-pertinent FDA divisions. Experts from Cytel periodically train the department’s statisticians in East’s new capabilities, and also the advances in adaptive trial methodologies.

Link: http://www.cytel.com/Software/East.aspx

Clindex® Clinical Trial and Data Management System

2009-09-18T11:06:00.000-07:00

Clindex enhances study database design, methodology and administration and streamlines data entry and tracking of CRFs, payment of CRFs and study monitoring. Clindex also provides powerful reporting functionality — from standard out-of-the-box reports, to ad hoc reporting capabilities, to data extraction for statistical analysis and study archival. With integrated functions to support all the steps in the clinical trial process, Clindex has an intuitive user interface and an open architecture to allow users and study administrators to customize their own solutions.

Link: http://www.fortressmedical.com/solTrial.htm

Dacima

2009-09-16T23:22:00.000-07:00

Dacima Software's proprietary database platform offers tremendous flexibility and has been designed to meet all health/medical and academic research community needs. It can be used for a wide range of disciplines, types of research projects and study designs. The database platform can be used for Clinical Trials, epidemiological studies (cross-sectional, cohort, case-control), basic sciences research or sociological research.

Features:

* Extremely easy to use
* User-friendly design
* Affordable and cost effective
* Can be used Offline (stand-alone computer or on a Local Area Network) or Online with remote data entry with data safely stored on secure servers.
* Meets regulatory compliance requirements for customers conducting clinical trials
* Allows any user to create professional databases
* No programming skills or knowledge of database design theory is required
* Rapid database development time
* Manage all your databases from one application

Link: http://www.dacimasoftware.com/en/Products.html#B

ClearTrial Clinical Trial Operations Planning (CTOP)

2009-09-15T01:25:00.000-07:00

The ClearTrial Clinical Trial Operations Planning (CTOP) software suite harmonizes operations across Clinical Planning, Outsourcing, Resource/ Project Planning, Finance, and outside stakeholders, ensuring that everyone is working from the same plan. It lets you assess multiple clinical development strategies, and determine the one that will best meet your business goals -- through a consistent, repeatable, and fast planning process.

Features:

* Quickly and easily create resource/capacity plans, study budgets, and outsourcing schedules
* Optimize operational plans for the business goals/constraints
* Improve communication across internal and external groups
* Gain visibility, in advance, to key metrics, milestones, dates, resource needs
* Proactively adapt to study changes
* Enhance accruals forecasting and tracking
* Improve control and communication in outsourcing
* Dramatically reduce external and internal costs

Link: http://www.cleartrial.com/products-and-services/product-overview

ClinPlus® Report (CPR)

2009-09-14T05:03:00.000-07:00

ClinPlus® Report (CPR) is SAS® based software designed to create high-quality statistical tables and listings quickly and easily from all types of data. Its unmatched versatility accommodates complex statistical summary tables to simple data listings and is the reason why it has been adopted as a standard by many including several of the top ten pharmaceutical companies. Three major components comprise this powerful system:

* The Report Engine, the foundation of the system, has been used by pharmaceutical companies in the U.S. and internationally since 1989. This engine does not rely on canned procedures like Proc Report, Proc Tabulate or Proc Print for report presentation, eliminating many limitations inherent in those procedures while retaining data-driven re-usability.

* The Report GUI (Graphical User Interface) provides point-and-click access to the Report Engine. This eliminates syntax errors and extends the system to a wide range of users. The Report GUI allows you to create and manage pure meta-data templates that can be recalled, modified and used to create stand-alone SAS programs. Other features such as a global titles and footnotes library and format builder are included.

* The RTF Engine is used to generate true RTF (Rich Text Format) tables for your final report without modification. This proprietary engine (not relying on SAS’s ODS) was designed with medical writers from major pharmaceutical companies to meet their complex demands. A single RTF style sheet may be used for all data presentations.

Link: http://www.clinplus.com/report.aspx

SiZ®

2009-09-11T00:09:00.000-07:00

SiZ® modernizes the clinical trial planning process by combining design, simulation and comparison of trial options, plus study data analysis within a single interface.

SiZ® is Cytel's fully referenced, easily learned trial design and analysis software for fixed sample size clinical studies featuring:

* a wide array of validated methods in an especially intuitive interface, easy even for first-time users
* trial simulations to rapidly and accurately compare designs
* a range of readily generated tables, graphs and plots to easily share designs amongst planning team members
* the only software that also analyzes trial data, eliminating the need for separate design and analysis applications

Link: http://www.cytel.com/Software/SiZ_main.aspx

EastSurv™

2009-09-10T09:49:00.000-07:00

EastSurv™ is the premier survival study design tool that reduces typical trial duration, subjects and costs in oncology and cardiovascular and infectious disease studies, including HIV and hepatitis.

Features:

EastSurv helps trials designers make the toughest design decisions with confidence by accounting for:

1. Variable subject drop-outs
2. Non-uniform accrual
3. Non-constant hazard rates
4. Variable and fixed subject follow-up
5. Lagged treatment effects and other non-proportional hazards scenarios

Link: http://www.cytel.com/Software/EastSurv.aspx

Quality Assurance Manager - Clinical Research

2009-09-09T01:31:00.000-07:00

Job Description

SOP review, development and implementation

• training of staff and investigators on GCP and GLP and SOPs

• auditing of CROs, clinical investigator sites and other vendors for GCP compliance

• scheduling and conducting independent inspections and quality audits (pre-study audit, during study audit, post study audits and follow up with audit reports) of clinical trials projects.

• preparing for regulatory Audits

• review of study related documents like study protocol, ICF, CRF and final report as per international norms

• reporting compliance issues and ensuring corrective actions.

Desired Candidate Profile

• More than 2-3 years experience in Clinical Quality Assurance in reputed Pharma or CRO.

• Auditing of clinical sites with either CRO or Pharma involved in conducting clinical Phase I/ II/III clinical trials

• Candidate must have Good analytical & communication skills.

Location : Mumbai
Name of the Company : wockhardt limited
Website : http://www.wockhardt.com

Clinical Data Coordinator

2009-09-07T10:23:00.000-07:00

Job Description

Working within a highly qualified team performing data management activities to ensure the generation of accurate, complete, and consistent clinical databases. Fulfilling your job responsibilities in accordance with Good Clinical Practices (GCPs), ICON Standard Operating Procedures (SOPs), Working Procedures (WPs), Study Specific Procedures (SSPs), International Committee on Harmonization (ICH) Guidelines, and all applicable laws and regulations.

Additional Responsibilities:

• Working independently and proactively you will Review Case Report Form (CRF) data for completeness, accuracy, and consistency identifying and resolving data discrepancies

• Update/correct/review data in the clinical databases based on resolved data queries

• Assist with the testing of data entry screens and the preparation of the relevant testing documentation.

• Create and maintain study files and other appropriate study documentation

• Dependent on level of experience you may assist in training and mentoring less experienced CDC’s.

• CDC should have an exposure on oncology, neurology and endocrinology trials; had an hands-on experience on InForm platforms to perform various tasks of validation. CDC should play a role of point of contact/ co-ordinated a team to manage study deliverables. Overall experience in data validation should be in between 1-2 yrs of experience.

Location: Madrid

Education:

UG - B.Pharma - Pharmacy,B.Sc - Any Specialization,

PG - M.A - Any Specialization.

Experience: 1 - 2 Years(MUST HAVE INFORM AND CLINTRIAL AND AT LEAST 2 YEARS EXPERIENCE AS A CLINICAL DATA COORDINATOR)

Company Name: Icon Clinical Research India Private Limited

Address:
Icon Clinical Research India Private Limited
123/124, Ispahani Centre Uttamar Gandhi Salai
Nungambakkam
CHENNAI,Tamilnadu,India 600001

Email Address: caroline.yeates@iconplc.com

Telephone: 91-44-42240531

TrialMax®

2009-09-05T13:22:00.000-07:00

TrialMax® eDiary design tool has been developed specifically to provide rich functionality. It enables clinical trial sponsors to collect primary and secondary efficacy data in shorter timescales and to conduct complex clinical trials with greater flexibility than any other ePRO solution. The TrialMax® eDiary eliminates the error-prone manual processes, providing more flexibility, more time to design effective eDiaries and the potential for more detailed yet simpler to use eDiaries, all of which result in improved data accuracy and a typical compliance rate of 95%. The individual components of the TrialMax® eDiary provide a comprehensive suite of tools to design, manage and host global ePRO studies in phases I to IV via mobile PDA devices, mobile phones and the Internet.

Link: http://www.crfhealth.com/prods_trialmax.php

CoMotion Trials

2009-08-31T09:37:00.000-07:00

It is a version of the Viz CoMotion software developed by military contractor General Dynamics for battlefield information sharing, is being demonstrated at the DIA show. Viz is part of General Dynamics C4 Systems.

Array BioPharma is currently using the software. Array has eight candidate drugs for inflammatory and metabolic diseases and cancer at the preclinical or later stages.

The software helps analysts and researchers visualize and share trial information by letting them embed, publish and distribute interactive visualizations into web pages for real-time collaboration.

Link : http://www.fiercebiotechit.com/story/software-uses-battlefield-intelligence-clinical-trial-ops/2009-06-24

Marketing and Sales Support Executive

2009-08-28T10:35:00.000-07:00

Job Description

The candidate will need to browse the web, use database lists to search for prospects. Email and tellecalling will need to be done to explore opportunities and set up meetings / con calls for domestic and international customers

Desired Candidate Profile

The candidate must have a good command over written and spoken English and should be good at using ms-office products, email and the internet. Experience in sales tele-calling is required.

Company Profile

MSCRPl is a focussed dermatology clinical research and testing facility based out of Bangalore catering to domestic and international clients.

Experience : 1 - 3 Years
Location : Bengaluru/Bangalore
Company Name : MS Clinical Research Pvt. Ltd.
Website : http://www.mscr.inExecutive Name: Ish Chowdhary
Email Address : mscrpl@gmail.com

Clinical Research Coordinator

2009-08-27T10:44:00.000-07:00

Job Description :

Site & PI identification as per the specific needs of Client & Protocol, Regulatory submission, IRB submission, Site set up, Document collection, Create source document, template and Prepare site for SIV.

Desired Candidate Profile :

Good communication skill
Can handle Pre screening, in case of chronic disease trials
Enroll & Follow Up
Coordinate Central Lab logistics & sample flow
Coordinate Monitoring & Audit visits
Create and Maintain local PI / Facility database.

Experience :1 - 2 Years
Location :Indore, Kolkata
Compensation:Rupees 1,75,000 - 2,25,000

Company Profile :

Excel Life Sciences (ELS) is a US-based provider of comprehensive clinical trial management services, focusing on site performance, patient enrollment and on-time study completion.

Website : http://www.excellifesciences.com

Office-Smart Clinical Trial Manager™

2009-08-25T10:20:00.000-07:00

For clinical trial professionals who want their study software to work with their Office software, TranSenda's Clinical Trial Manager is also available in an Office-based version. Unlike other clinical trial management systems, which function outside of office software, TranSenda's Office-Smart Clinical Trial Manager is designed to take full advantage of the powerful Microsoft® Office System. Office-Smart software delivers productivity gains that can save thousands of hours in the span of a study.

Key Features

1. Study configuration wizard enables dynamic site initiation for either single or multi-sponsor users.
2. Versatile set up accommodates SOPs, allows custom alert notification, protocol deviation tracking and more.
3. Context-intelligent navigation across standardized screens.
4. Seamless use of all Microsoft Office SharePoint Server features-such as Single Sign-On, which enables users to access multiple systems from one point.
5. SharePoint portal capabilities include document management, workflow collaboration, team sites and wiki sites.
6. Users can securely perform study-specific roles based on flexible operational permissions.
7. Robust scheduling functionality tracks and monitors patient visits and CRF receipts.

Link: http://www.transenda.com/products/office-smart-clinical-trial-manager

EDC Administrator

2009-08-21T11:01:00.000-07:00

Job Description :

The role is in charge of providing EDC systems administration and user support for EDC trial database systems that are used for all global Vaccines Development clinical trials, Phases I to IV ; maintaining security and assuring adherence to regulations, procedures and standards.
Main responsibilities :

• Assist in the Clinical Data Management (CDM) activities for several protocols and CDM projects
• Support EDC trial development and validation activities, including trouble shooting
• Produce and review EDC trial database validation deliverables
• Deploy EDC trials to internal servers Prepare deployment of (production) EDC trials at external hosting provider
• Manage user accounts and security for EDC trials (externally hosted)
• Provide user support for EDC trials (second line)
• Support decommission and archiving of EDC trials
• Support the upgrades of EDC trials and related systems including validation documentation development, review and execution
• Participate in the development and review of procedures and guidelines related to EDC trial administration
• Performs other duties as assigned

Desired Profile :

Good computer skills Relational databases Understands clinical data Good interpersonal and communication skills Problem solving skills Accurate worker with attention to relevant details Ability to set and meet deadlines Good organizational and time management skills.1 year in the biotechnology or pharmaceutical industry, preferably with direct clinical database system administration experience.

Experience: 1 - 3 Years

Contact : Novartis Healthcare Pvt Ltd

Website : http://www.novartis.com

Office-Smart Clinical Payment Manager™

2009-08-20T10:21:00.000-07:00

For clinical trial finance professionals who want their financial software to work with their study software and their Office software, TranSenda delivers the first and only Office-based clinical payment solution. Unlike other clinical trial payment systems, which function outside of office software, TranSenda’s Office-Smart Clinical Payment Manager is designed to take full advantage of the powerful Microsoft Office System.

Key Features:

1. Flexible study budget includes multiple contract version tracking, allowing study-specific payment rules methodology to apply on a site-specific basis
Unique payment programs can be designed for each service provider and investigator site
2.Ability to handle multiple payee types including investigators, contractors, vendors, and ad hoc
3. Track payments made to date, including accrued, in real-time against total study budget at study, site and subject levels
4. Actual payments due calculated on subject activities and milestones—can also be captured in Excel and automatically translated into invoice line items per payment rules
5.Supports currency exchange rate calculations for international sites
Payment details help ensure compliance with Sarbanes-Oxley and support emerging investigator payment laws.

Link: http://www.transenda.com/products/office-smart-clinical-payment-manager

ClinBUS Connector™

2009-08-19T07:12:00.000-07:00

ClinBUS Connector enables organizations to pull important operational data from third party clinical trial software, such as Electronic Data Capture (EDC), and make it available for use in TranSenda’s Office-Smart solutions. Based upon TranSenda’s ClinBUS™ data sharing technology, ClinBUS Connector allows software systems to share a set of pre-defined operational data with Office-Smart Clinical Trial Manager™ and Office-Smart Clinical Payment Manager™. ClinBUS Connector also makes data available through Microsoft SharePoint® Server and the Microsoft Office System. Opening key operational data to Microsoft’s powerful SharePoint and Office Systems enables the transformation of process information into useful knowledge.

Features

1.ClinBUS Connector is a licensed product, not a professional services offering

2.Includes Web service functionality to retrieve and update various records (e.g., Site, Study, Study Component, Study Component Visit, Subject, Subject Event, CRF Page and Serious Adverse Event, etc.)

3.ClinBUS Connector can be used for multiple software systems

4.TranSenda’s ClinBUS-based data connection technology is compatible with CDISC ODM data types

5.ClinBUS is optimized to leverage the Microsoft Office System
Web services-based data interchange to facilitate integration with disparate systems—in many cases without vendor professional services

Link: http://www.transenda.com/products/clinbus-connector

TraumaBase©

2009-08-18T10:15:00.000-07:00

Clinical Data Management has been in the business of providing Trauma Registry Software to hospital, regions and states for over twenty-five years. CDM systems verify hospital data for accuracy, meet state or regional data collecting requirements, produce state or regional electronic export files, and maintain the gold standard with customizable features and technical support services.

Key Features:

1. Optional Network Capability and Multi-Patient Incident Tracking
2. Customizable, Expandable User-Defined Data Elements
3. Multi-tier Systems, Meeting Different Facility Rquirements
4. Data Points Include National Consensus Data Sets
5. HIS Imports/Exports
6. Automatic Multi-Level Data Validation and Editing
7. Ad-Hoc Reporting and Standard Pre-Set Reporting Library
8. Meeting HIPAA Requirements
9. Automated Coding Assistance (e.g. ICD9, AIS, E-Codes)

Multi-Layered Security Options:

'Calculator' - Revised Trauma Score-Probablity of Survivial Trainer
Seamless Connections to Excel©, Word©, or Other Software
Automated Scoring Including ISS, RPS, RTS, TRISS and Others

Link: http://www.c-d-m.com/traumabase.html

ResearchBase©

2009-08-17T09:59:00.000-07:00

ReseachBase is the foundation from which all Clinical Data Management's data collection products are built. ResearchBase can be easily molded to special research projects by utilizing an extensive library of data collection tools.

Key Features:

1. Sophisticated Reporting Engines
2. QI/Review Modules
3. User-Friendly Import/Export Programs
4. Custom Pick-Lists
5. Custom Questionnaires
6. Multi-Study Ability
7. Built-In Security
8. Data Validation
9. Ad-Hoc Reports

Link: http://www.c-d-m.com/researchbase.html

CDM WinFRT

2009-08-14T03:11:00.000-07:00

CDM WinFrt is a Windows based, fully integrated software solution.

Key Features:

1. Simplified Data Entry with reduced screens for improved user efficiency
2. Shipment Template Feature for repetitive shipments
3. Integrated Data Validation to reduce data entry errors and shipment delays
4. Simplified Laser Forms avoids additional costs of pre-printed forms
5. Supplemental forms for shipments to specific countries
6. Integrated e-mail features allow users to send shipment documents and freight invoices to multiple parties
7. Integrated accounting modules allow management to tracking profitability by client, trade lane, agent, carrier, franchise station, etc

Link: http://www.cdmsoft.com/index2.php?s=content&p=winfrt

Report

2009-08-13T02:41:00.000-07:00

Powerful authoring tools for creating high-quality statistical tables and listings from all types of clinical data.

Features:

• The Report Engine, the foundation of the system, has been used by pharmaceutical companies in the U.S. and internationally since 1989. This engine does not rely on canned procedures like Proc Report, Proc Tabulate or Proc Print for report presentation, eliminating many limitations inherent in those procedures while retaining data-driven re-usability.

• The Report GUI (Graphical User Interface) provides point-and-click access to the Report Engine. This eliminates syntax errors and extends the system to a wide range of users. The Report GUI allows you to create and manage pure meta-data templates that can be recalled, modified and used to create stand-alone SAS programs. Other features such as a global titles and footnotes library and format builder are included.

• The RTF Engine is used to generate true RTF (Rich Text Format) tables for your final report without modification. This proprietary engine (not relying on SAS’s ODS) was designed with medical writers from major pharmaceutical companies to meet their complex demands. A single RTF style sheet may be used for all data presentations.

Link : http://www.clinplus.com/report.aspx

Perceptive Portal™

2009-08-10T02:12:00.000-07:00

Perceptive Portal™ is a powerful enterprise portal solution that provides an intelligent, centralized place for trial communities to access key trial information and documentation. Built by Perceptive’s experienced team of portal experts, our solution surfaces all the trial-related materials individual users require in a simple and intuitive framework. Built-in integration with Perceptive’s leading technology solutions and other third-party applications enables the calculation and display of valuable trial metrics consolidated from multiple sources, ensuring study management have accurate data to make reliable decisions. Study forums and announcements enable users to publish and access relevant study materials, communicate with other users and share best practice.

Features
• Built-in data integration with DataLabs® EDC, ClinPhone® RTSM, IMPACT® and TrialWorks® CTMS, Medical Imaging and ePRO with the ability to access and report data from other third-party solutions.

• Standard and configurable functionality including:

o Clinical Trial Metrics - View aggregated information across systems for strategic decision making at a trial-, program- and portfolio level
o My Applications - Link to the technology solutions in use including DataLabs EDC, ClinPhone RTSM and IMPACT or TrialWorks, Medical Imaging, ePRO and third-party applications
o Document Repository - Post and access the latest study documents
o Document Collaboration - Share and collaborate on the creation and approval of study documents
o Student Announcements - Publish and share study updates and announcements.

Link: http://www.perceptive.com/Solutions/Portal.html

Divisional Head - Clinical Research

2009-08-08T01:09:00.000-07:00

Job Description

To lead a research team.

Desired Candidate Profile

To lead a research team and closely work, Support & Guide Investigators within the institute & take the proactive role for partnership, collaboration with sponsor and stockholders of clinical research.

Company Profile
Associate Sister concern of Apollo Tyres

Experience : 5 - 10 Years

Location : Gurgaon

Compensation : Rupees 10,00,000 - 19,00,000.

Education : UG PG - B.Pharma.

Industry Type: Pharma/ Biotech/Clinical Research.

Contact Details

Company Name : Artemis Medicare Services Pvt. Ltd

Website : https://www.artemishospital.in
Executive Name: HR Department

Email Address :annie@artemishealthsciences.com

Reference ID : AHI_CR_01

Zipsor

2009-08-05T10:37:00.002-07:00

Generic Name : diclofenac potassium
Date of Approval: June 16, 2009

The U.S. Food and Drug Administration (FDA) has approved Zipsor (diclofenac potassium) Liquid Filled Capsules for the relief of mild to moderate acute pain in adults (18 years of age or older).

Link: http://www.drugs.com/zipsor.html

Data Manager

2009-08-03T09:35:00.000-07:00

Job Description

Provide timely and professional ongoing management of clinical trial data by identifying and resolving errors and inconsistencies in eCRF data to ensure consistently high standard database(s) with respect to cost, quality and timelines.

Key Areas

1.Provide professional DM input on Clinical Trial Team(s)
2.Input to and review of clinical trial database design including User Acceptance Test-ing (UAT). 3.Responsible for the Validation and Analysis Plan (VAP) meeting for the clinical trial, which includes chairing the meeting, writing the study specific validation checks and necessary reports to ensure high quality and consistent data.
4.Identify errors and inconsistencies; resolve them or initiate their resolution either via the field monitor or directly with the investigational site, to ensure high quality and timely database locks.
5.Review and contribute to preparation of protocols, specifically related to the data management section, visit schema and study design.
6.Prepare Case Report Forms (CRFs) and CRF completion Guidelines (CCGs), elec-tronic or paper.
7.Support and provide leadership for data management staff for allocated trials.
8.Freeze and lock data as appropriate in time for statistical review, blinded interim quality review, interim and final database lock.
9.Perform training on data management software and practices or trial specific topics as required.
10.Prepare training materials for data management activities and processes as re-quired.
11. Serve as Project Data Manager for large projects or multiple smaller projects providing professional Data Management input on ICT(s). 12.Travel is required as needed.

Experience : 2 - 4 Years
Education : UG - Any Graduate PG - Any PG Course - Any Specialization.
Location : Hyderabad / Secunderabad Keywords Data management.
Contact : Novartis Healthcare Pvt Ltd
Website : http://www.novartis.com/

Effient - Recently Approved Drug by FDA

2009-08-01T05:45:00.000-07:00

Generic Name : prasugrel
Date of Approval : July 10, 2009

The U.S. Food and Drug Administration (FDA) has approved Effient (prasugrel) for the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndromes who are managed with an artery-opening procedure known as percutaneous coronary intervention (PCI).

Link: http://www.drugs.com/effient.html

Lead Clinical Research Associate

2009-07-31T08:11:00.000-07:00

Job Description

Day to day leadership and management of monitoring services for clinical projects including direct communication and interaction with investigative sites/monitors. Delivers monitoring services to Project management.

Desired Candidate Profile

Manage Clinical Monitor site assigment&schedules.Conduct project comonitoring visits and team training.Site contact for protocol clarifications&subject enrollment.Protocol deviation documentation.

Company Profile

Paragon Biomedical is a contract research organization with headquaters in Irvine( California) UK,Polland and India.Paragon Specializes in the management of International phase I-IV clinical trials in a wide range of therapeutical area.

Experience : 3 - 5 Years
Location : Trivandrum
Compensation : Rupees 4,00,000 - 5,00,000
Education : UG - B.Sc - Any Specialization, PG - M.Sc - Any Specialization

Contact Details

Company Name : Paragon Biomedical India P Ltd

Website : http://parabio.com

Executive Name: Vinod Narayanan

Email Address : recruit_india@parabio.com

Multaq - Recently Approved Drug by FDA

2009-07-30T08:46:00.000-07:00

Generic Name : dronedarone
Date of Approval : July 1, 2009

The U.S. Food and Drug Administration (FDA) has approved Multaq (dronedarone), an anti-arrhythmic indicated to reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent episode of AF/AFL and associated cardiovascular risk factors, who are in sinus rhythm or who will be cardioverted. Associated cardiovascular risk factors include age over 70 years, hypertension, diabetes, prior cerebrovascular accident, left atrial diameter greater than or equal to 50 mm or left ventricular ejection fraction [LVEF] <40%.>

Link : http://www.drugs.com/multaq.html

Clinical Research Associate

2009-07-29T01:21:00.000-07:00

Job Description

• Identify and qualify potential investigational sites.
• Coordinate and perform comprehensive site management.
• Conduct pre-study selection, site initiation, interim and close out monitoring visits
• Assist Project Manager/Clinical Trials Manager in completing and drafting study related plans
• Submit comprehensive visit reports and status reports in a timely manner
• Resolve and/or escalate logistical, data and audit issues
• Adhere to the study timelines and budget, in line with managers’ expectations
• Collect and review trial essential documents and prepare documents for ethics committee and/or regulatory submissions and supervise filing or assist in filing of essential documents
• Prepare materials for presentation at investigator meetings or site initiations and other project-related forums
• Ratio of travel and in-house activities (expected average): 70%:30%
• Handling inspections by regulatory agencies or (internal/external) audits.

Desired Candidate Profile

• Minimum 2 years of clinical research experience for CRA
• Life Science degree or equivalent or Registered Nurse
• Fluent in the English language and local languages as required for the performance of source data verification and communications; strong written and verbal communication in English
• Knowledge of ICH-GCP and applicable local and international regulatory guidelines (preferred)
• Demonstrated knowledge of clinical monitoring, follow company SOPs and applicable regulatory requirements
• Attention to detail and a methodical and systematic approach to work
• Strong interpersonal skills and an ability to communicate at all levels
• A proven ability to organize, take initiative and follow-up independently
• Knowledge of computer software: Microsoft Word, Excel, PowerPoint, Project, Visio, Outlook; SharePoint (preferred)
• Ability to travel up to 70% of time
• Candidate should have Minimum of a Bachelor of Science degree in a relevant scientific discipline.

Experience: 2 - 6 Years
Location : Bengaluru/Bangalore

Contact Details

Company Name : Adamas India Pharmaceuticals Pvt. Ltd.
Website : http://www.adamaspharma.com.
Executive Name : Bindhu John
Email Address : hr@adamaspharma.com

Cambia - Recently Approved Drug by FDA

2009-07-28T08:40:00.000-07:00

Generic Name : diclofenac potassium for oral solutionDate of Approval: June 17, 2009

The U.S. Food and Drug Administration (FDA) has approved Cambia, a diclofenac-based non-steroidal anti-inflammatory drug ("NSAID") combined with potassium bicarbonate, for the treatment of acute migraine with or without aura in adults.
Cambia, formulated with KPA's patented Dynamic Buffering Technology (DBT), was specifically developed to address widespread unmet needs among patients by offering fast and effective relief of migraine pain. In randomized clinical trials, Cambia was shown to be effective not only in migraine pain, but also in treating photophobia (sensitivity to light), phonophobia (sensitivity to sound), and nausea commonly associated with migraine attacks. It was also shown to provide statistically significant onset of relief of migraine pain within 15 to 30 minutes.

Link: http://www.drugs.com/cambia.html

Ozurdex - Recently Approved Drug By U.S FDA

2009-07-27T10:28:00.000-07:00

Generic Name: dexamethasone intravitreal implant
Date of Approval: June 17, 2009

The United States Food and Drug Administration (FDA) has approved Ozurdex (dexamethasone intravitreal implant) 0.7 mg as the first drug therapy indicated for the treatment of macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO).

Ozurdex is a first-of-its kind therapy administered via intravitreal injection delivering dexamethasone, a highly potent corticosteroid, via Allergan's proprietary and innovative NOVADUR solid polymer delivery system. Via the NOVADUR delivery system, Ozurdex, a biodegradable implant which enables the extended release and effect of dexamethasone, is placed in the vitreous cavity in the back of the eye treating the macular edema associated with RVO, thereby improving a patient's visual acuity.

LINK: http : www.drugs.com/ozurdex.html

Caldolor - Recently Approved Drug by U.S FDA

2009-07-24T08:03:00.000-07:00

Generic Name : ibuprofenDate of Approval: June 11, 2009.

The U.S. Food and Drug Administration has approved Caldolor, the first injectable dosage form of the common pain medication ibuprofen, to treat pain and fever.
Caldolor will be available for hospital use only. It is approved to be administered in 400 mg to 800 mg doses, over 30 minutes, every 6 hours for acute pain. To treat fever, the drug is approved in a 400 mg dose administered over 30 minutes, followed by 400 mg every 4 to 6 hours, or 100-200 mg every 4 hours, as necessary.

Link: http://www.drugs.com/caldolor.html

Recently Approved Drug By U.S FDA

2009-07-23T03:44:00.000-07:00

Date of Approval: July 16, 2009

The U.S. Food and Drug Administration (FDA) has approved Onsolis (fentanyl buccal soluble film) for the management of breakthrough pain in patients with cancer.

Onsolis consists of a small, dissolvable, polymer film, formulated with the opioid narcotic fentanyl for application to the buccal mucosa (inner lining of the cheek). Onsolis adheres to the buccal mucosa in seconds, starts to dissolve in minutes and delivers fentanyl across the mucosa for relief of breakthrough pain (BTP) in patients with cancer, eighteen years of age and older, who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.

Link : http://www.drugs.com/onsolis.html

Pharma - Project Trainee

2009-07-22T03:49:00.000-07:00

Job Description : The incubment will be working on Projects in the area of Clinical Trials, Pharmacovigilance, Pharma Regulatory Affairs, GMP etc. The project duration is 6 months. Renewable only in case of exceptional performance.

Desired Candidate Profile : The incumbent will be working on Content / Documentation Projects in areas of Pharma Regulatory Affairs, Clinical Trials, Pharmacovigilance etc .

Experience : 0 - 1 Years
Location : Noida
Compensation : Rupees 70,000 - 80,000Rs 5000 PM for D Pharma, Rs 6000 - MSc Pharma.
Education: UG - B.Pharma - Pharmacy,Diploma - Any Specialization,Other Graduate - Any Specialization

Company Profile : BII is an pioneer and innovative organisation working in emerging Bioinformatics, IT, IPR and pharma areas. It is known all over the world for its pioneering approach. BII Programs are taken up by pharma, Legal professionals across the world.

Company Name : BIOINFORMATICS INSTITUTE OF INDIA

Website : http://www.bii.in

Safety Processing Expert

2009-07-21T04:00:00.000-07:00

Job Description : Facilitates safety monitoring by optimizing scientific quality documentation and data entry of safety case reports for Novartis drugs. Responsible for the receipt, tracking and initialization of single case drug safety reports in to the safety database; accurate data entry and coding of adverse event reports and evaluation of non-expeditable reports within well defined timeframes, in compliance with DS&E business rules, standard operating procedures and regulatory requirements.

Desired Profile : Medical Degree (MBBS) or Bachelors Degree in Pharmacy or Advanced Nursing Degree or Masters Degree in life sciences or related fields; or equivalent combination in educational credentials and experience Preferred : MD or MS in Clinical Pharmacy, PhD in Life sciences .

Languages: Good knowledge/fluency in English. Knowledge of other languages desirable. Experience/Professional requirement:
• Familiarity with medical terminology
• Ability to write clearly and concisely
• Self motivation and proactive stance to work
• Sense of urgency and commitment for timely comple-tion of activities
• Prior Medical Transcription or Medical Writing experi-ence preferred
• Previous safety or clinical trial experience desirable, but not essential
• Previous data entry experience desirable, but not essential

Experience : 1 - 6 Years
Location : Hyderabad / Secunderabad
Keywords : Pharmacovigilance, Single case reporting, Aggregate reporting, RMP
Contact : Novartis Healthcare Pvt Ltd
Website : http://www.novartis.com/

IXRS ™

2009-07-20T00:24:00.000-07:00

IXRS ™ (Interactive Voice and Web Response System) is the central hub of our integrated suite of services. For more than 13 years, Almac Clinical Technologies has been a leading provider of Interactive Voice Response Systems (IVRS) for clinical trials. Now, our IXR systems allow users the convenience and flexibility of managing traditional IVRS activities in real time over the phone (IVR), the web (IWR), or both.

Almac’s IXRS ™ features the following:

1. Dynamic patient randomisation & dosing
2. Patient tracking and management
3. Clinical trials supplies management
4. Drug inventory management planning
5. Integration with Almac’s iTrial EDC™
6. Standard and customized reporting
7. Robust solution for clinical/drug supply management

Almac’s Interactive Voice and Web Response System provides the following benefits to clients:

1. Fully configurable and customizable
2. Facilitates Adaptive Trials and other complex designs
3. Multi-lingual capabilities to support global trials
4. User-friendly interface
5. Highly scaleable infrastructure
6. Standard, custom, and ad-hoc reporting
7. Integration with our EDC and e-PRO products
8. Integration with sponsor and vendor systems
9. Experienced project management
10. In-house statistical support for complex randomizations
11. In-House Almac 24.7.365 Global Technical Support

Link: http://www.almacgroup.com/clinicaltechnologies/ivrs-iwrs-ixrs.aspx

TrialSense

2009-07-17T08:30:00.001-07:00

The TrialSense Collection Station provides a window through which subject data is easily entered. Accessed from any modern operating system using a standard Web browser, it combines strong security and privacy protection mechanisms with an easy-to-use interface where clinicians and users enroll and select subjects, enter and review case report forms, and recognize possible adverse events.

TrialSense supports the concurrent management of multiple trials. Through a single, common user environment, clinicians can enroll subjects, and enter and review data, for different studies. Trials can be configured to run in multiple sites around the world, enabling instantaneous transmission of data from any point of participant contact to a central trial data repository. For locations where access to the Internet is unavailable or unfeasible, TrialSense provides offline data collection with advanced synchronization using highly portable devices such as Tablet PCs.

Link: http://www.infotechsoft.com/trialsense.htm

Database of AIDS Vaccine Candidates in Clinical Trials

2009-07-17T08:29:00.000-07:00

This database provides information about the clinical trials of preventive AIDS vaccine candidates—those intended for individuals who are not infected with HIV—that are designed to prevent HIV infection or disease. This database does not have any information on clinical trials to evaluate the therapeutic effects of AIDS vaccine candidates in people who are already HIV infected.Information on the trials and candidates in the database is updated regularly in collaboration with several organizations and individuals involved in this work.
Link: http://www.iavireport.org/trials-db/Pages/default.aspx

BioPoint™ Rapid Registry Patient Check-In System

2009-07-15T07:05:00.000-07:00

BioPoint™ Rapid Registry Patient Check-In System provides an easy to use kiosk that allows patients to self-register and receive arrival instructions. It automatically relays information to notification screens across the hospital, providing staff with real-time arrival notification and information. Integration with vital signs collection stations and other information systems saves time and reduces errors.

Features :

* Rapid patient identification through ID, driver’s license and other scans

* Communicates arrival instructions and prints required paperwork

* Instant notification of patient arrival and real-time status

* Integrates with vital sign collection stations and other information systems

* Customer support team provides ongoing training and help

Link: http://www.bio-optronics.com/Products/bioPoint/RapidRegistryPatientCheckin.aspx

StrataTracks®

2009-07-14T06:47:00.000-07:00

StrataTracks® makes it easy to get answers to your questions quickly and manage your trials efficiently. Users can place orders, upload files, generate reports, monitor activity, and utilize many other features.

StrataTracks® has the flexibility to allow you to be proactive! If a question arises from the field, you can locate accurate and up-to-date information online instantly, without time consuming research and callbacks and the problematic delays that they cause.

StrataTracks® has been developed and enhanced to its current version over a 12+ year cycle. It tracks every aspect of your CRFs from the moment they are ordered until they arrive at their destination.

Shipping costs can be a significant percentage of your total business costs. However, these costs can often be reduced by careful planning, communications and control. Strata’s unique online StrataTracks® logistics management system provides greater control over these types of decisions.

Link: http://www.gostrata.com/pharma/stratatracks.html

Momentum™ Imaging Center Patient Scheduler

2009-07-13T03:15:00.000-07:00

Momentum™ Patient Scheduler is the only intuitive, automated software solution that intelligently assures availability of resources, and simultaneously takes into account patient preferences, utilization, and specialized needs, when scheduling appointments.

Features :

* Evolves easily as needs and preferences change

* Complete library of reports for optimizing performance

* Supports practices of all sizes and complexity

* Hosted solution accessible via web browser

* Customer support team provides legacy data imports, training and ongoing help

* Provides feedback to Momentum™ Staff Scheduler for better staffing planning (coming soon) * Integrates with Momentum™ Day-of-Care workflow (coming soon)

Link: http://www.bio-optronics.com/Products/Momentum/ImagingCenterPatientScheduler.aspx

Clinical Trial Results Database

2009-07-09T23:01:00.000-07:00

The Clinical Trial Results Database contains completed international industry- and government- sponsored trials and their results.The database is searchable by medical condition or drug name and information generally includes a brief summary of the study, location, objective, drug performance, and more. Results are added as information becomes available, making this resource a great way to stay up-to-date on the latest outcomes in clinical research.

Links:
Results by Medical Condition: http://www.centerwatch.com/clinical-trials/results/db/area.html
Results by Drug or Therapy Name: http://www.centerwatch.com/clinical-trials/results/db/drug.html

e-CRF+™ Application Hosting

2009-07-09T22:53:00.000-07:00

With e-CRF+™ Hosted Application, you can avoid the lengthy time delay and costs associated with installing, validating , and maintaining in-house CTMS systems. Once you subscribe to our hosted application, you simply connect directly into e-CRF+™ secure servers. Your entire trial team can start using our system to design and manage your clinical trials immediately. ECRFPlus provides and maintains all the hardware and software needed, so you never have to hassle with technology, upgrades, or large scale validation. ECRFPlus offers an array of hosted solutions.

Depending on your needs, you may choose one or many of solutions below:
CTMS
ECG
ABPM
EDC Supply & Logistics
ePRO/eDiary
Custom Applications

Visit : http://www.ecrfplus.com/ecrfplusHosted.asp

PVPlan

2009-07-08T22:21:00.000-07:00

ProSanos' PVPlan software enables you to create and manage a Pharmacovigilance Plan, in accordance with the EU Risk Management Plan Template (EU-RMP) .

FEATURES
* Document Safety Concerns and associated actions throughout the product lifecycle, with an easy-to-use, web based platform.
* Develop and maintain a Pharmacovigilance Plan consistent with EMEA Risk Management Plan (EU-RMP) template.
* Share information and manage pharmacovigilance actions among diverse and/or geographically distributed teams.
* Option to integrate the results of quantitative signal detection into the documentation process

LINK: http://www.prosanos.com/pvplan.php

SÆfetyWorks®

2009-07-07T21:47:00.000-07:00

SÆfetyWorks is a web-based software application enabling Safety Scientists and Epidemiologists to rapidly query and analyze disparate observational (claims and electronic health record) databases.

FEATURES:
Rapidly create, view, and export patient cohorts of interest in large observational data bases
Gain an understanding of the real-world, quantitative context for a given cohort (demographics, most common concomitant medications, most common co-morbid conditions)
Perform targeted multivariate analyses to assess the strength of association between a drug condition pair, controlling for important covariates
Analyze multiple databases using a single protocol and analysis definition, using an interactive, guided process
Augment current signal detection practices with an exploratory framework to identify and prioritize drug condition pairs that warrant further investigation.

Link: http://www.prosanos.com/saefetyworks.php

CLÆRITY®

2009-07-07T21:46:00.000-07:00

CLÆRITY is easy-to-use web-based software for investigation and management of potential safety signals in adverse event data
FEATURS:
Signal investigation for multiple SRS databases, including: FDA AERS, FDA VAERS and Internal Company SRS Data
Detect and investigate potential safety signals
Manage and monitor signals of interest over time
Document and track outstanding actions
Use complementary data mining technologies (PVmaps®, PRR, MGPS) for full coverag
Link: http://www.prosanos.com/claerity.php

SAS Programmer

2009-07-02T08:18:00.000-07:00

Designation: SAS Programmer/ Statistical Analyst in Pharmaceutical(Clinical) Domain

Job Description

We need people who thrive on technology challenges and are driven by fast paced work environments. We are currently recruiting SAS Clinical Programmers.

Desired Profile

If you are a Technical graduate/post graduate, with more than 3 years of experience in SAS Programming with clinical domain and if you are willing to work for Chennai location.

Please apply to the given option

Role: SAS Programmer/ Statistical Analyst in Pharmaceutical(Clinical) Domain

Over All Purpose of the job:

Create SAS datasets of clinical data from Biometric databases; create status and efficacy datasets

Create project specific macros and formats

Create summary tables, listings and graphs as per statistical analysis plan

Responsibilities/Authorities

Serve as contact with clients for programming aspects of clinical studies

Review shell data displays for consistency and to ensure that all CRF fields are displayed on listings.

Ensure overall consistency of a project including macro definitions,

Debugging programs, and documentation.

Perform data checks as needed to ensure integrity and correctness of data

displays

Preparing documentation for programs and project

Maintain project directories on UNIX/Windows computer systems, including

Ensuring that final SAS output is in the correct directory,

Requirements

Proficient in SAS

Graduate/Post graduate with Very Good Experience in SAS Programming

Working knowledge of the procedures of clinical programming-Preferred

Experience on either UNIX or PC platform using SAS

If the above mentioned requirement sounds exciting to you and If you are interested to apply for this role with Accenture, then send your updated resume to us to the below mentioned Emai

Address

Adarsh PB,
adarsh.pb@accenture.com
+918040773194

Accenture is an Equal Opportunity Employer

Experience: 4 - 9 Years

Education: UG - Any Graduate - Any Specialization PG - Any PG Course - Any Specialization

Location Chennai
Keywords SAS PROGRAMMERCLINICAL PROGRAMMER

Contact: Accenture

Website: http://www.accenture.com

Sy/Validate™

2009-07-01T08:59:00.000-07:00

Compliance Made Easy Sy/Validate is a user-friendly verification and validation tool for SAS programs. It automates the task of creating an audit trail of programs directly within Windows Explorer. This tool has many features that will enable your programs to be CFR Part 11 compliant.
Validation Made Easy Sy/Validate has all the essential features to allow you to apply version control over your SAS programs, MSWord Documents, Excel Spreadsheets and PDF files.
Visit :http://meta-x.com/sy_validate.html