Lean Six Sigma uses data and statistical analyses to measure and improve a company's operational performance by identifying and eliminating defects in processes. Historically, Six Sigma has been mainly used in the manufacturing process but the benefits to research and development (R&D) processes have recently been highlighted, in particular applications in early phase research. This article reviews the challenges of applying the Lean Six Sigma methodology in the clinical trial Phase 1.
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Fran�ois Marti (2005) studied this question.
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