Contract Research Organization Excellence: Driving Bioequivalence Testing Program Effectiveness

Contract research organizations (CROs) play a vital role in bringing new generic drugs to market through their management of the critical bioequivalence studies that are required for generic drug products. However, CROs face the continual challenge of carrying out complex activities that result in the manufacture of high quality products while maintaining a low-cost structure that enables them to survive in the very competitive CRO marketplace.

Best Practices, LLC conducted this research study to generate valuable business and clinical insights that can help CRO leaders improve efficiency and reduce costs in conducting bioequivalence studies. Specifically this study identifies key cost, quality and productivity metrics for the process of conducting the bioequivalence studies required to bring a new generic drug to market.

CRO leaders and executives providing bioequivalence services for generics manufacturers can use the comparative data in this benchmarking research to evaluate and improve bioequivalence program effectiveness within their organizations.

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

Qualitative and quantitative data for this study were collected through an online survey instrument. Participants in this benchmarking research included 27 executives and managers at 26 different Contract Research Organizations (CROs). 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.

Key topics include:

• Geographic Trends
• Volume & Cost Metrics
• Bioequivalence Practices & Processes
• Sponsor Relationships & Support
• Best Practices
• Lessons Learned

Sample Key Findings

Cost/Price Pressure Is Top Future Challenge: Price erosion, increased competition, regulatory changes and generics industry mergers are the key concerns of CROs working with generics companies. Severe price pressure is the greatest challenge noted by the benchmark class.

• Future Outsourcing: CROs expect to increase bioequivalence 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 bioequivalence activities in Russia.

If you purchase Best Practice Database document(s), you will have 30 days from the date of purchase to apply some or all of the cost of the document(s) toward the cost of a Full Access Individual, Pharma, Group or University Membership. Write us at DatabaseTeam@bestpracticesllc.com or call David Guinn at 919-767-9179 if you have any questions.