Planning Quality into Clinical Trials

Drug developers are focusing significant attention on risk-based monitoring (RBM) of clinical trials to improve data quality, trial efficiency and patient safety. Widely encouraged by regulatory agencies, RBM adoption is gradually building momentum as sponsors and contract research organizations (CROs) concentrate on developing the right strategies, deploying the most effective technologies and internally managing change.

PerkinElmer Informatics has produced two of a three-part series of white papers on RBM: "Speeding the Switch to RBM" and "The Foundation of Risk-Based Monitoring Success." This paper is part three of the series, presenting industry progress in developing and implementing a systematic approach to RBM, integrating Quality by Design (QbD) and RBM, and change management and planning for broader implementation.

PerkinElmer Risk Based Monitoring Solutions

White Paper