After all the complaining that "quality" is not great in Indian CRO's we often miss the whole poing about quality. Lets break this discussion into two levels : 1. How is quality measured, 2. How to improve quality in your clinical trials ?
Quality in clinical trials is a product of reliability & credibility and compliance to the protocol/process specified by sponsor/client. The customer or client is looking at fulfilling requirements such as : budget, legal regulations, ethical guidelines, study protocol, time frame and GXP. Most of the large MNCs have Quality Management Systems (QMS) to
establish and consistently achieve quality objectives. QMS are structured into training, SOP/procedures, Quality Control and Quality Assurance.
Procedures and SOPs can be specific to a sponsor or to an investigator site. SOPs clearly define the timeframe, specifications of input and output and most importantly the role of each team member. They also serve as tools for training and for change management.
Quality control : systematic checks on the compliance of the trial process & reliability and credibility of data
Quality Assurance : independent audits of all trial-related processess & functions. Can be trial or project specific or system audits.
Hi to setup a CRO in india,do u have any basic information? Have u got any consultancy in your mind?
ReplyDeleteIf so please suggest information,thought of to setup an initial CRO for pahse 3 and phase 4.
hi
ReplyDeleteSetting up a CRO in India is easy assuming that you have the finances in place. However if you want to do phase 3 studies you will need to start atleast with phase 2A to build your experience. Most of late phase CROs are started by acquiring existing players. Currently the market for CROs is huge in india, consider partnership with MNCs - they bring a wealth of experience and most importantly the brand.
we can provide consultancy in this direction, with the complete project plan and regulatory requirements needed.
Contact : satish@clinnovo.com