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Clinical programs at pharmaceutical organizations are increasingly looking to less expensive and regulated areas of the world to perform clinical trial activities. A parallel consideration is the use of outsourcing for clinical activities in emerging markets.
However, there are still questions around the cost, quality and pitfalls of conducting clinical trials in emerging regions and using outsourcing in those regions.
Best Practices®, LLC conducted this study to inform clinical affairs leaders at pharmaceutical companies on benchmarks around outsourcing attributes, CRA, CRM and CRD competencies and outsourcing levels for those functions, clinical affairs structure, and outsourcing trends. In addition, the study presents outsourcing success factors and pitfalls from participants' qualitative responses.
This report will inform Clinical Affairs leaders on these questions and others regarding outsourcing and managing clinical trials outside of the U.S.
Seven participants from six pharmaceutical companies participated. The study attracted a strong group of experienced pharmaceutical Clinical Affairs executives. Two were at the vice president level and five were at the director level. In addition, four in-depth interviews were conducted to capture innovative practices in clinical activities in emerging areas.
Health Care; Pharmaceutical; Biotech; Medical Device
Eisai; Abbott Laboratories; Daiichi Sankyo; CSL Behring; Roche; Merck Serono