Case processing (ICSRs)
PrimeVigilance uses a validated ARISg safety database – the Industry standard - and our staff have been entering individual case safety reports for the last 5 years. Our system server is secure, with appropriate back-up and disaster recovery programmes in place.
We offer a cost-effective solution for managing your historic safety data as well as taking care of your company’s future needs for processing individual case safety reports. Our experienced safety physicians are involved in reviewing MedDRA coding and in the assessment of all cases. 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 understand the need for 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: regular management reports, routine signal detection, database searches for signal evaluation, periodic safety update reports or responses to regulatory authority enquiry: all attract the same attention to quality and application of medical expertise. At PrimeVigilance, if it needs a medic we use a medic, but it need not cost you the earth.
ICSRs: Compliant and Complete
- just one of the pharmacovigilance services from PrimeVigilance
For more information contact PrimeVigilance today