Case Processing (ICSRs)

Virtual PV can either use its own validated safety database or, if it is more convenient, enter data directly into your database. Because our team is virtual and every member has been processing individual case safety reports and pharmacovigilance data for at least 5 years we can provide you with a high quality, cost-effective solution for managing your case processing needs.

Our experienced safety physicians are involved in reviewing MedDRA coding and in the assessment of all cases and we carry out full quality control on each report.

Our staff are trained in the use of Eudravigilance for electronic reporting and case disposition is tracked and contributes to metrics for regulatory and quality compliance monitoring.

We appreciate the importance of keeping to time, for making the right decisions about expedited reporting and for keeping the appropriate people in your company informed, and if necessary we can tailor our established standard practices to your specific requirements. The whole system is subject to internal audit and is also open to your scrutiny.

However, entering data into a safety database is only a small part of the requirements for pharmacovigilance and we can provide: regular management reports, routine signal detection, database searches for signal evaluation, periodic safety update reports and responses to regulatory authority enquiries which all attract the same attention to quality and application of medical expertise.