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

Abstract

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. A library of risk indicators has been created, and this paper provides additional guidance on what has been learned in the application of these tools. Results: The goal is to share the needs related to people, process, and technology as experienced by TransCelerate member companies. Conclusions: One of the primary issue detection methods of central monitoring is the proactive identification of areas of focus through the use of risk indicators.