The Adverse Event Reporting System (AERS) is a database designed to support the FDA's post-marketing safety surveillance program for all approved drug and therapeutic biologic products. MedWatch® is an AERS developed by FDA for collecting reports of adverse reactions and quality problems with drugs, medical devices and other FDA regulated products such as dietary supplements. Data collected from the MedWatch system and adverse drug reaction reports from manufacturers are part of the AERS public database.

PSC can help you meet global regulatory compliance in this area. We can help you implement AERS systems and tailor the system to your needs. Our expertise includes:

Relsys International Argus Safety™
Argus Safety™ provides case data management and regulatory reporting in the pharmaceutical industry. It includes a centralized easy-to-use web-based system for managing drug safety data, allowing instant world-wide availability of a case report. It supports any global workflow model and can be configured to process case reports according to your unique business processes.

ARISg™
Aris Global™ provides a comprehensive range of software solutions for the life sciences industry, including Total Safety, a suite of solutions for pharmacovigilance and safety. It allows you to implement proactive surveillance programs and take a long-term approach to manage the safety of your products. This suite of tools includes a modular gateway for the exchange of electronic information, inbound receipt and triage of adverse event information, clinical safety reconciliation system, comprehensive periodic and aggregate reporting system and advanced signal detection and data mining system.




Oracle®
Oracle® AERS is another adverse event reporting system that allows you to monitor adverse events encountered in clinical trials so that safety concerns can be addressed early in the device development life cycle. It also allows you to report adverse reactions and complaints in a timely fashion in all countries where your products are marketed or studied. The system integrates fully with other Oracle® products such as Oracle® Clinical, and helps prevent duplicate effort or database discrepancies.