Home 9 Pharmacovigilance 9 Pharmacovigilance Database
Pharmacovigilance Database
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;
- Line-listings;
- Summary tabulations.
In addition, Biomapas team has experience and is ready to support work in any other customer database too (e.g. ARGUS, ARISg, LSMV)
All Post-AUthorization Services
Continued Lifecycle Patient Safety.
