Medical Monitoring in Non-Interventional Studies: Need for Medical Leadership and Study Primary Care Management
Jean Siebenaler, MD, MPH
Senior Medical Director, Real World Evidence
Mapi/ICON, United States
This session will describe and compare in details the role of the medical monitor in the use of non-interventional studies (NIS) versus explanatory clinical trials from the preparation to the end of the study and provide best practices and desirable profile for the medical monitor. We will explore the challenges of the implementation of a solid medical monitoring to conduct the NIS in an optimal way.
Learning Objective : Compare the roles of a medical monitor in non-interventional post-authorization studies versus clinical trials in pre-approval setting; Discuss needs and best profile for the position.