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To further the understanding of opportunities, challenges and benefits of implementing a quality metrics program, ISPE, in cooperation with McKinsey and Company, established the ISPE Quality Metrics Pilot Project in 2013. The Pilot was designed to define and operationalize standard metrics reporting to the FDA and refine the proposed set of metrics and definitions, data submission process and evaluation. A detailed report from Wave 1, provides data and explanations for findings from the Pilot, Wave 1, success factors and next steps for ISPE's Quality Metrics Initiative.
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