Pharmaceutical companies are on a constant lookout to improve efficiency and reduce costs when conducting bioequivalence studies. Thus, they increasingly use contract research organizations (CROs) to conduct these critical studies. This not only helps to reduce costs, but it also has been proved to produce efficient clinical trial results. Also, CROs are often challenged with competitive prices and are constantly looking at further enhancing the quality of their testing programs.
Best Practices, LLC conducted the research that led to this report to provide benchmarking data that CROs can use to evaluate the performance of their bioequivalence testing programs. Specifically, this research 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 management insights, lessons learned and best practices for productivity in the bioequivalence study process.