Science Driven CRO

Science Driven CRO


Medical Management in Clinical Trials (02): A Roadmap to Operational Excellence. Part 2: Study Setup

We previously introduced you to “Medical Management in Clinical Trials: A Roadmap to Operational Excellence”, which represents the first article of a series that discourse about the role of the responsible Medical Monitor during the various milestones of a clinical trial.

While the first part was focused on the Development Phase of a Clinical Trial study, the second article of these series covers the key contribution of the Research Physician / Medical Monitor during the Set Up Phase of Clinical Study:

“In this edition of the Medical Management series, the responsibilities of a clinical research physician, the study Medical Monitor (MM), during the study setup phase starting from Clinical Trial Application (CTA) till the recruitment of first patient will be detailed. This phase holds significance for the study MM, as the blueprint for Medical Management and the associated tools to accomplish the project specific goals and deliverables will be contrived during this period. The clearer and more robust the medical procedures are defined in the concerned documents, the more streamlined it gets later during the study conduct and close-out phases. Further, the ground rules that structure the safety standards of the study and the integrity of the patient data collected are laid out during this phase.”

We invite you to read the entire article (pages 26-29) in the Journal for Clinical Studies by clicking the cover image.