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Products & Services

CRO Bioequivalence Strategies: Performance Metrics, Processes & Trends

ID: POP-233


Features:

18 Data Graphics

97 Metrics

6 Narratives

3 Best Practices


Pages: 43


Published: Pre-2014


Delivery Format: Shipped


 

License Options:
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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.




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919-403-0251

  • STUDY OVERVIEW
  • BENCHMARK CLASS
  • STUDY SNAPSHOT
  • KEY FINDINGS
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.


Industries Profiled:
Computer Software; Clinical Research; Pharmaceutical; Research; Health Care; Biotech


Companies Profiled:
Kronos; Alticure Research Pvt Ltd; Abridge Clinical Research; PPD; Actimus Bio; Veeda Clinical Research; Algorithme Pharma; Anapharm; Assign Group Clinical Research; bioRASI; Celerion; Chiltern; CNS; CR Bio; Fortis Clinical Research; FP Clinical Pharma SRL; Info Kinetics; Medpace; Micro Therapeutic Research; Norwich; Novum; PharmaMedica; Q-Pharm; Quartesian; Terapia; Vimta Labs

Study Snapshot

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.

  • Future Outsourcing: CROs expect to increase BE activities in less-regulated regions in the next 24 months, especially in India, China and Eastern Europe, where 68%, 67% and 64% respectively, expect increases. Only 11% plan more BE activities in Russia.