Medical Monitoring

Our Medical Monitors possess broad, practical clinical experience in a variety of therapeutic areas. They have both clinical and research experience, and some serve as Principal Investigators. They are able to apply their practical knowledge and experience to present solutions for the issues that occur in clinical research studies.

Medical Monitoring Services include:

  • Providing Support to Sites by Addressing Investigator Questions Regarding Appropriate Interpretation/Application of the Study Protocol
  • Advising on Appropriate Medical Management of Subject Emergencies
  • Providing Clinical Development Plans and Protocol Design Input
  • Training Staff and Investigators
  • Serving as Medical Director to Sponsors without Medical Staff
  • 24/7 Medical Monitor Coverage
  • Enhancement of Regulatory Compliance
  • Clarifying Inclusion/Exclusion Criteria with the Investigators
  • Providing Consultation for Potential Safety Issues or Medical Concerns Regarding the Clinical Study
  • Identifying and Evaluating Safety Signals, Trends and Events
  • Medical Review and Evaluation of Serious Adverse Events (SAEs)
  • Providing Medical Review of Protocols and Clinical Study Reports (CSRs)