The Refuge Health team of medical monitors and clinical scientist are trained clinical research professionals with many years of leadership experience in the field of clinical drug development across a wide range of therapeutic indications.

We are committed to providing flexible, timely, cost saving, and quality services that are tailored to support every need of our clients. Our medical and scientific clinical trial experts are available to assist participating sites and investigators globally.

Refuge Health services include

(but are not limited to)

  • Serving as medical monitors and clinical scientist to sponsors in need of a medical monitoring team
  • Interacting with clinical sites by answering investigator site questions about the protocol and trial
  • 24/7 Unblinding coverage and medical emergency contact
  • Providing therapeutic and project specific training
  • Clinical Investigation Plan design and writing
  • Protocol design, and risk assessments
  • Subject eligibility verification
  • Reconciliation of protocol deviations
  • Serious adverse event review and reporting
  • Reviewing and analyzing study level data for safety and efficacy trends
  • Providing input on study team deliverables, such as final narratives and clinical study reports

Literature Review and
Scientific Document Writing

  • Perform literature review to support clinical development plan, publications and presentations.
  • Develop the protocol, informed consent form, investigator brochure, case narratives, and clinical Study Report
  • Prepare scientific slides for investigator meetings, abstracts, manuscripts, and posters for publication

Clinical Data Review
and Cleaning

  • Review trial level data to identify trends in safety or efficacy endpoints
  • Interpret clinical trial data and incorporate into clinical study report
  • Conduct clinical data review and cleaning for database lock

Clinical Trial Operations
and Scientific Support

  • Provide medical monitoring expertise to clinical operations and other cross-functional teams
  • Train site investigator, study coordinator, CROs on therapeutic area and clinical study protocol
  • Serve as scientific resource for resolving issues during clinical study conduct

For more information on medical monitoring services, please complete our request for proposal form.