Medical Monitoring Services

Our Medical Monitors provide medical review and management of clinical trial activities for our clients. Our Medical Monitors have extensive training and experience across a wide range of therapeutic areas and technological platforms. Our Medical Monitors can work independently or become fully embedded in the client teams. They are often involved in preparing for first-in-man trials, and can bridge all phases of clinical trials. In addition to Medical Monitors, we offer Chief Medical Officer Services.

Medical Monitoring Core Services:

  • Product Development planning
  • Document design, review and sign off from a medical point of view (Investigator Brochure, Protocol, CRF, Informed Consent, Study Manual, Statistical Analyses Plan, Data Validation Plan, Study Reports, SAE narratives
  • Study decisions regarding in/exclusion deviations, dosing questions, concomitant medication requests, emergencies (including 24/7 coverage)
  • Listing review of study data listing (demographics, physical exams, vitals, dosing, labs, EKG, concomitant medications, adverse events, efficacy parameters, protocol deviations) and cross referencing critical data fields for consistency
  • Coding review
  • Trend analyses for safety parameters during the trial
  • Data clarification
  • SAE narrative writing and submissions to regulatory
  • SAE reconciliation and coding
  • Literature evaluations (scientific, efficacy, safety and competitive analyses)

In addition to the responsibilities of a Medical Monitor, Clinquest’s Chief Medical Officers can meet your managerial and public relations needs.

Chief Medical Officer Core Services:

  • Project team and upper management medical advice and guidance regarding the medical aspects of the project
  • Overall guidance regarding the development plan for the entity under study (pre-clinical to post-marketing)
  • Clinical Team leadership, as needed
  • Introductions to thought leaders
  • Liaison with potential clinical investigators, thought leaders and regulatory authorities
  • Liaison or participate with other parties such as Advisory Boards, Data Safety Monitoring Boards, Vendors, Investors, VC’s and Boards
  • Regulatory responsibility for clinical trial safety assessments across a development program (such as FDA form 1571)