Effective processing of clinical trial safety data is imperative to the successful conduct of a clinical trial.
With years of experience in clinical trial management, we offer effective management of clinical trial SAEs from case assessment through to expedited reporting of SUSARs (Suspected Unexpected Serious Adverse Reactions) to the regulatory authorities as well as Annual Safety Reports (ASRs) which have to be submitted to regulatory authorities and Ethics Committees throughout the course of the clinical trial programme.
PrimeVigilance can take care of all of your Clinical Trial Safety requirements, including forming a data safety monitoring board.
Once your company holds a marketing authorisation, regulatory requirements change. We can take care of all of your requirements for case processing, expedited reporting, periodic safety update reports (PSURs), literature screening and safety signal detection and review – in fact we can provide and run your entire pharmacovigilance operation.
+44 (0)1483 307920
(+1) 781 703 5540
United Kingdom (Head Office)