A Knowledge Management Framework and Approach for Clinical Development

A knowledge management (KM) framework enhances knowledge gathering, sharing, application, and retention within clinical development and enables the effective and successful implementation of a clinical quality management system (QMS). The goal of managing knowledge is to improve organizational performance by getting the right information to the right people at the right time. The concepts of KM have been around for decades but, to date, have not been widely adopted within the clinical development arena. Implementing a structured approach and strategy to managing knowledge can enable more timely and informed decision making, enhance quality and productivity, and ultimately support the delivery of new products to patients. This paper outlines in general terms key elements of a clinical knowledge management (CKM) framework to assist clinical development organizations in understanding its benefits and basic components. Ideas are provided at a high level for flexible approaches and solutions aimed to enhance knowledge gathering, sharing, application, and retention within clinical development.

Source: Therapeutic Innovation and Regulatory Science - August 25, 2016 Category: Drugs & Pharmacology Authors: Salzano, K. A., Maurer, C. A., Wyvratt, J. M., Stewart, T., Peck, J., Rygiel, B., Petree, T. Tags: Sponsored Special Section by TransCelerate BioPharma Source Type: research