Individual Case Safety Reports (ICSRs) Management

Our team is experienced in handling end to end case processing of spontaneous, literature and clinical trial origin ICSRs using Argus, ARISg, PvNet, ABCube, BaseCon & Eudravigilance databases. We, in association with European solution providers offer a pharmacovigilance technology platform solution that helps clients reduce manual effort in ICSRs processing.

Pharmavigil experts place particular emphasis on the timely reporting of the case reports. With a choice of fully validated and compliant safety database solutions, highly effective SOPs and operating guidelines in place, thorough employee training, and a constant quality management system ‘on time’ reporting is a major priority. Reports may be made electronically or by hard copy as required by the applicable regulations.