Clinical Medical Monitoring

MGH CTNI Medical Monitoring

The CTNI Medical Monitoring team is led by Dr. Marlene P. Freeman.  CTNI Medical Monitors provide medical review and management of clinical trial activities for our clients. Our Monitors have extensive training and experience and are all board certified psychiatrists with an average of over 10 years of clinical trial experience, as principal investigators of NIH funded trials, and as site investigators for industry trials.  Our medical monitors work collaboratively with the site PIs and the sponsor to ensure patient safety and trial integrity.

Clinical Medical Monitoring Core Services:

• 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 review and submissions to regulatory
• SAE reconciliation and coding
• Literature evaluations (scientific, efficacy, safety and competitive analyses)