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Regulatory & Medical

Medical Monitoring & Pharmacovigilance

Physician-led medical monitoring, safety case processing and regulatory safety reporting.

What's Included

  • Medical monitoring and medical support for sites, including out-of-hours coverage as agreed per study
  • Medical Monitoring Plans and Safety Management Plans
  • Eligibility review and protocol clarification support
  • SAE/SUSAR intake, processing, MedDRA coding and case narratives
  • Expedited reporting (IND safety reports, CIOMS, E2B) and periodic reports (DSUR, PBRER)
  • Safety database set-up, configuration and legacy data migration
  • Signal detection, evaluation and management
  • Aggregate safety reviews and line-listing review
  • Reference safety information and Investigator's Brochure safety sections
  • DSMB/IDMC set-up, charter development, meeting and documentation support
  • Risk Management Plans and post-marketing pharmacovigilance

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