Science Driven CRO

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Medical Management in Clinical Trials (03): A Roadmap to Operational Excellence. Part 3: Study Conduct Phase

Knowledge building and information sharing pertain to the founding vision  at Europital. “Medical Management in Clinical Trials: A Roadmap to Operational Excellence” is series of articles hat discourse about the role of the responsible Medical Monitor during the various milestones of a clinical trial.

In this third article of the Medical Management series, the various monitoring activities undertaken by a Clinical Research Physician assuming the role of Medical Monitor (MM) during the course of study conduct are presented and discussed:

 “The Study Conduct Phase requires inherent medical monitoring activities that involves day-to-day medical review and site guidance. The procedure and pathways defined in Medical Monitoring Plan (MMP), Protocol Deviations (PDs) guidance document and Safety Management Plan (SMP) are executed as planned to drive the study progression in the right direction, meeting study specific milestones and projections in the process. In this phase, the Lead MM holds the reins for all medical management activities that occur in tandem throughout the study conduct. The conventional industry practice for large phase 3 studies is to designate a Lead MM along with as many regional MM’s as required by the landscape of the study.”

We invite you to read the entire article (pages 16-22) in the Journal for Clinical Studies by clicking the cover image.