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3 Best Practices
Single User: Authorizes use by the person who places the order or for whom the order was placed.
Sitewide: Authorizes use of the report for a geographic site. All people at site can view the report for a year and copies can be printed.
Corporate: Authorizes use for the entire company for a year and copies can be printed. No limitations for usage inside the company.
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.
Twenty-seven executives and managers from 26 different Contract Research Organizations (CROs) participated in this benchmarking study. About two-thirds of the participants hold job titles of director or above, and 41% represent business development groups. Most of the participants are located in India, the United States or Canada. Qualitative and quantitative data for this report were collected through an online survey instrument.
Sample Key Findings
Use of Less Regulated Regions: A majority of participating CROs (57%) conducts bioequivalence studies in at least one less-regulated region, such as India, China, Russia or Eastern Europe. India is the most commonly used of these regions.