Biomapas pharmacovigilance and clinical safety management services are supported by a fully E2B and CFR21 Part 11 compliant database.
Our safety database has an integrated submission management tool for direct submissions, complex search functionality and simplified signal detection. It enables E2B-compliant XML file import and export, recording of Individual Case Safety Reports (ICSRs) and the generation of:
- CIOMS I format reports;
- MedWatch format reports;
- Summary tabulations.