Serious Adverse Events and Adverse Drug Reaction Management

PRA's Drug Safety Centers in close cooperation with PRA Medical Affairs provide all aspects of safety management related to processing of Serious Adverse Events and Adverse Drug Reaction reports. Services include:

24/7 medical and safety coverage
Protocol or Product specific Safety & Medical Management Plans
SAE/ADR: Receipt & Acknowledgement, Triage, Data-entry, Narrative writing (sequential or CIOMS V formats), Analysis of Similar Events, Medical Review, Assessment of Relatedness and Expedited Reportability, Quality Control, Expedited Reporting to Health Authorities, AE/SAE reconciliation
Literature search
Central repository of regulatory reporting requirements for more than 60 countries
Translation management
Oracle web-based, fully validated Safety Letter Tracking System (SLTS)

PRA Safety Database Experience

PRA's Drug Safety Associates have expertise with a variety of widely used commercial safety databases and individual client developed databases. Commercial database experience includes:

Partnership

For larger clients, PRA is able to integrate seamlessly into the client's pharmacovigilance department. PRA offers services "à la carte" and operates in the client's safety database.

For small or middle size clients, PRA is able to operate the client's virtual pharmacovigilance department. PRA is able to host and maintain the safety database on behalf of our client. We are committed to providing flexibility for our clients and help them to choose the option that best meets their needs.