Abstract
Process improvement has been a dominant movement in many manufacturing industries in the last two decades. In recent years, many service- and transactional-based companies are successfully implementing Six Sigma to improve business success. Most of the pharmaceutical and biopharmaceutical companies have not broadly recognized integration of breakthrough process improvement methods with clinical research practices. Although this phenomenon is interdisciplinary, its internal structure and the nature of its interactions with other disciplines in clinical development organizations have not been studied in depth. This article will discuss the author's comparative analysis of the Six Sigma and other quality management methodology. A case study is also presented to demonstrate breakthrough reduction of cycle time in Clinical Report Form entry process with near zero defect level of quality.
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