Designing and running clinical trials is very complicated and expensive and, in many ways, each trial is unique. However, by applying general manufacturing principles and thinking, it is possible to distill out those processes that are common to all trials and show their interconnected nature, both operationally and mathematically. This approach allows clinical trial performance to be characterized by a limited number of independent variables, and clinical trial performance to be optimized so that the clinical trial “manufacturing line” produces its “final product”, clean data, in the quickest, and most cost-effective manner possible.

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Article published in Chronicle PharmaBiz | 13 July, 2019 and CIOReviewIndia | July, 2019

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