Medical Monitoring

Medical Monitoring

Board-certified medical monitors at Aptiv Solutions work closely with the Sponsor and each internal project group throughout the course of a study and through each phase of development. They are involved with discussions of patient eligibility, management and protocol deviations. They also interact with project teams to perform medical review of study documents including protocols, CRFs, adverse events and the clinical study re-port.

  • Patient eligibility verification
  • Treatment compliance
  • Protocol deviations
  • Product development strategies
  • Sponsor representation with Regulatory Agencies
  • Study and protocol design
  • Review and trend analysis of Safety or Efficacy Data Points
  • Literature evaluation (Disease Background, Competitor Analysis)