Safety

Safety is paramount during all phases of clinical research.

We can provide the following medical monitoring services:

  • Medical support to sites for study protocol interpretation and subject medical management
  • Medical review and assessment of serious adverse event reports
  • Preparation of serious adverse event narratives for regulatory reporting or inclusion in clinical study reports
  • Assistance with, and participation in, Data Safety Monitoring Boards
  • Timely receipt, processing and communication of initial serious adverse event reports and follow-up to case closure
  • Safety reporting in compliance with local regulatory requirements
  • Preparation and distribution of investigator notification letters.