Services
Accovion, as a full-service CRO, provides extensive experience in data management and in pharmacovigilance services. This background serves as the solid foundation for the most efficient and regulatory-compliant reconciliation of serious adverse event data between the clinical database and the pharmacovigilance database, regardless of system used – yours, ours or a third-party system.
We identify the discrepancies, determine their source and decide on the appropriate action:
- Correction of data in the clinical database
- Amendment of data in the pharmacovigilance database
- Seeking for additional information from the investigator
This process is fully documented, performed in accordance with a specific SOP and continues until all serious adverse events are reconciled up to closure of the clinical database.
Carole Martini
Director Clinical Data Management
+49 6196 7709-433
