Confidence Beyond Compliance

We offer the full range of case processing services from collection, triage, database entry, creation of checklists defining the fields to be assessed and breaking them down into criticality (with an appropriate set of KPIs tailored as per client’s needs), coding and medical assessment to regulatory submission. Our drug safety specialists will take over single aspects or the entire case processing. We can operate with your own pharmacovigilance database, or provide you with a complete case processing solution that includes a validated, E2B(R3)-compatible database and capable of retrieval of report and safety data for regulatory reporting and safety reports preparation purposes. PharmaLex’s Vigicare ICSR processing occurs in all PharmaLex main country hubs. Understanding that great delocalization is one of the most critical challenges in the industry, PharmaLex offers high flexibility to adjust to changing demand. PharmaLex works with an established validated network of representatives covering local presence in regions worldwide. This established network leverages over more than 15 years of working together to ensure reliability and trust. Our services run within a quality-assured framework (ISO 9001 certified) and are regularly inspected by competent authorities without any critical or major findings. ICSR management and expedited reporting of local / country specific ICSR and follow-up request management, including translation to a full range of case processing: collection, data entry, QC, medical review & reporting.