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Generics manufacturers are on a constant lookout to improve efficiency and reduce costs when conducting the required bioequivalence studies for their new products. Thus, they often turn to contract research organizations (CROs) to conduct these critical studies. This not only helps to reduce costs, but it also produces efficient clinical trial results. However, CROs are under constant pressure to reduce costs to survive in the competitive CRO sector while maintaining the high quality work needed to conduct the complex activities required for bioequivalence studies.
Best Practices ®, LLC developed this report to help enhance CRO bioequivalent study processes in spite of these hurdles. Specifically, this study aims to identify key cost, quality and productivity metrics for the process of conducting bioequivalence studies required to bring a new generic drug to market. In addition to metrics, the study includes executive insights, lessons learned and best practices for productivity in the bioequivalence study process.