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White Paper

Planning Quality into Clinical Trials

Introduction

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.

Download this paper to learn more about developing and implementing a systematic approach to RBM, integrating Quality by Design (QbD) and RBM, and change management and planning for broader implementation.