Abstract
The challenge of quality improvement extends beyond traditional service delivery organizations. This is the first of a two-part series on the application of continuous quality improvement (CQI) to contract research organizations associated with the pharmaceutical and biotechnology industry. The challenges and processes of clinical trials research, and the role of CQI within that process, are presented. The importance of customer focus, which is a key element of CQI, is described here as the foundation of the CQI process among contract research organizations (CROs) and as a major contributing factor to their success in recent years.
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