PRA has four Drug Safety Centers located in Germany, the UK, the US and Brazil. These centers work in close cooperation with PRA Medical Affairs to provide the full spectrum of safety management related to the processing of Serious Adverse Events (SAEs), Adverse Drug Reactions (ADR) and Medical Device Reports (MDR).
Our safety management services include:
- 24/7 medical and safety coverage
- Protocol- or product-specific safety and medical management planning
- SAE/ADR/MDR services include receipt and acknowledgement, triage, data-entry, narrative writing, analysis of similar events, medical review, assessment of relatedness, expectedness and expedited reportability, quality control, expedited reporting to regulatory authorities and AE/SAE reconciliation
- Communications services including:
- Management of safety reports
- Literature searching
- Collating and reporting regulatory safety reporting requirements for more than 60 countries
- Translation management
- E2B reporting and Oracle web-based, fully validated Safety Letter Tracking System (SLTS)
- e-Safety letter distribution
- Safety database experience with a variety of widely used commercial safety databases:
- Oracle AERS
- ARGUS
- ARISg
