Adverse Event Management and Reporting

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 Biotech 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:

Oracle

Oracle Argus Safety is an advanced and comprehensive adverse events (AE) management system that helps life sciences companies enable regulatory compliance, drive product stewardship, and integrate safety and risk management into one comprehensive platform. Argus Safety is industry-proven and accepted, having been used for more than a decade at leading pharmaceutical, biotech, CRO, and medical device manufacturers.

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.

If you would like more information, get in contact with us directly here.