PrimeVigilance’s expertise encompasses both pre and post marketing pharmacovigilance.
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 PrimeVigilance offers 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. PrimeVigilance is able to 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.
PrimeVigilance can provide the EU Qualified Person for Pharmacovigilance, and a validated ARISgTM safety database, electronic reporting to Eudravigilance along with preparation of your DDPS (Detailed Description of Pharmacovigilance System), your Standard Operating Procedures and safety data exchange agreements. We are uniquely placed to be able to provide top specialist assistance such as the production of risk management plans (RMPs), responding to regulatory enquiries, helping with assessment of benefit and risk and assisting in responding to safety concerns. We also carry out training, including inspection preparedness training and have world class experience in performing audits. We can then can help you implement any corrective actions that may be necessary. PrimeVigilance offers all the component parts needed to help ensure drug safety, for your compliant and effective pharmacovigilance system.