Pharmacovigilance

Active Pharmacovigilance services is part of our  integrated clinical research offerings. We can provide support to sponsors across desired time zones. Our SOPs for pharmacovigilance operations are compliant to global regulatory and GPvP guidelines

Proscizen’s drug safety data management services includes but are not limited to -

  1. Safety monitoring plan
  2. Safety data base creation and configuration support
  3. Safety database change and maintenance

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  4. Case reception, encoding and reconciliation
  5. Case narrative writing
  6. Case assessment
  7. Processing medical information request
  8. Review of literature reports
  9. Reportability analysis, compliance reporting and follow up
  10. Submission support for expedited safety reports including SUSAR, Annual safety report, PSURs
  11.  Investigator Alert Letters
  12. EMEA Eudravigilance Registration and Testing
  13. Analysis of Similar Events

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  14. AE/SAE Reconciliation
  15. Pregnancy reports
  16. Post-Marketed Safety Surveillance:

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