Clinical trial safety
PrimeVigilance staff have years of experience using a validated ARISg safety database – the Industry standard – for managing serious adverse events from clinical trials. In addition to entering individual cases in the database and providing medical review of cases, we can handle reporting to clinical trial investigators, ethics committees and regulatory authorities world-wide for your clinical trial reports.
Ongoing monitoring of clinical trial safety, preparing annual safety reports or IND Annual reports, establishing data safety monitoring boards – PrimeVigilance can provide all that you need for the day-to-day management of SAEs in clinical trials.
And when it comes to updating the Investigator Brochure, writing Development Core Safety Information and generating Development Risk Management Plans, our consultants are available to help with these as well.
Clinical trial safety: Compliant and Credible
- just one of the pharmacovigilance services from PrimeVigilance
For more information contact PrimeVigilance today