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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.

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