Pharmacovigilance

Clinical Pharmacovigilance

  • 24 x 7 Call receipt & Triage
  • Processing of SAEs & electronic reporting
  • Causality assessment
  • Clinical Trials Safety Data Management
  • Clinical Study Reports and Annual Reports 

Medical Information

  • Call receipt 24X7
  • Call Management
  • Call routing to appropriate stakeholder
  • Call triaging and information capture in database
  • Management of standard and off label customer inquiries
  • Management of complete cycle from receipt of inquiries to response
  • Capture of inquiries in database

Post-Marketing Pharmacovigilance

  • Data entry into validated electronic database including historic safety data
  • Quality control
  • Medical review, narrative writing, MedDRA coding
  • Reporting: Electronic (E2B), Hard copy (CIOMS, MedWatch 3500A drug, etc.)
  • Complete PSUR/PADER generation
  • Literature searches
  • Signal Detection- Benefit Risk Evaluation & Risk Management

Safety Database Consulting

  • Implementation and Validation of Oracle® Argus Safety™ Suite, Oracle® AERS, ARISg, and other commercial off the shelf adverse event reporting systems.
  • E-Submission Gateway Set-up, Pilot Testing with Agencies including FDA and EMEA
  • Requirement specification and system selection.
  • Drug safety and regulatory reporting business processes.
  • Post go live support to address system administration, application administration and business support