Defining a Central Monitoring Capability: Sharing the Experience of TransCelerate BioPharma's Approach, Part 2.

Background: TransCelerate's model approach to risk-based monitoring (RBM) includes the application of the appropriate monitoring activities to enable both the early detection and timely resolution of issues. This article is a follow-up to part 1, published in the September 2014 issue with the same title.

Methods: The intent of this paper is to share information on what has been learned by various companies' applications of central monitoring activities based on different RBM operating models.