Abstract
AbstractMany CQA (clinical quality assurance) units were just being formed in the United States in the early 1980s, but are now commonly recognized components of Quality Assurance. CQA units operate in a unique environment when compared to GMP (good manufacturing practice) and GLP (good laboratory practice) units, and have vast responsibilities with regard to the magnitude and constantly changing nature of the clinical research activities they serve. The uniqueness and enormity of this task demands strategically planned activities that are designed to maximize the benefit of each CQA professional on staff. A number of methods are discussed in this article. Increased focus will deliver CQA into a new era of high impact. If properly focused and directed, CQA can serve as a small fulcrum to leverage big change in clinical research. This change is not limited to improved GCP compliance and quality, but can significantly improve company efficiency and profitability as well. Copyright © 2003 John Wiley & Sons, Ltd.
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