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Medical Monitoring

Medical Monitoring

Our Medical Monitors are skilled clinical development professionals. They have an average of more than 25 years of both clinical and industry drug development experience in a variety of therapeutic areas. We provide strategic and specific advice to our Sponsors and work closely with the sites and investigators throughout the life of each study.

Services include:

(but not limited to):

  • Provide input on the clinical development plan and protocol design including, but not limited to, patient selection, site selection, endpoint determination, and feasibility assessment.
  • Provide ongoing support to the sites and study protocol-related questions, including the protocol inclusion/exclusion criteria, concomitant medications, medical conditions, follow-up visits, and guidance on prohibited medication etc.
  • Server 24/7 emergency coverage for safety-related matters and advise on the medical management of subject emergencies.
  • Review of subject safety-related data and address safety issues across the study from sites and the study team.
  • Provide medical review of clinical study report.
  • Train staff and investigators.