Clinical Medical Monitoring ServicesOur medical Monitors provide medical review and management of clinical trial activities for our clients. Our Monitors have extensive training and experience across a wide range of therapeutic areas and technological platforms. Our 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. Clinical 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 (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)
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