Providing Input Throughout the Clinical Trial Lifecycle

  • Generate clinical content for publications, data review/safety meetings, decision-making task forces, and Agency/IRB communications
  • Provide medical monitoring support, including review of protocol deviations, line listings, and medical coding, generation of queries, and hosting of regular medical monitoring meetings
  • Develop solutions (eg, team site, trackers) to enhance medical monitoring efficiency and oversight of both patients and CRO activities
  • Serve as site and CRO point of contact for protocol-related questions
  • Develop clinical content, including:
  • CDPs
  • CRFs
  • ICFs
  • Study manuals
  • Perform safety reviews and case processing
  • Undertake medical coding and deviations reviews
  • Provide site communications support