Adverse Event Reporting Systems (AERS)

AERS reporting is a non-trivial and mandatory process for all pharmaceutical and device manufacturers. There are number of software packages support both registering the safety events as well as reporting them to different regulatory agencies worldwide. Here is a summary and links to the product websites. If you wish to specialize in pharmacovigilance you will have to be good with at least one and familiar with all of them.

Argus Safety™ Web

Very strong package supporting global reporting, integration of multiple safety terminologies (MedDRA, COSTART, WHO-ART etc,). It is built on a web-based technology and integrates well with risk management software.

http://www.relsys-inc.com/products/argus_safety/

Clintrace

Another powerful safety reporting system from PhaseForward. This is also built on a web-based technology and support multiple regulatory submission formats.

https://www.phaseforward.com/jp/products/safety/aer/documents/ClintraceDataSheet072506.pdf

ARISg™

It has similarities to Argus in terms of the platform and functionality. Their website informs that it is deployed with two regulatory authorities.

http://www.arisglobal.com/product_arisg.php

Oracle AERS

We found it a bit difficult to work with, please take this as a personal opinion. The best feature in addition to other tools is Signal Identification and Safety Surveillance. However this functionality can be achieved by other data visualization and reporting tools on top of any AERS system.

http://www.oracle.com/industries/life_sciences/adverse-event.html

E2B software tools

E2B is the industry standard for secure transmission of safety data. There are couple of tools in this arena but we found PPD's E2B functionality to be robust.

http://www.ppdi.com/services/post_approval/technology_services/software/e2b_consulting.htm