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Clinical programs at medical device 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 medical device 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.
Research participants included 13 executives and managers from 11 medical device companies across a wide variety of therapeutic areas and product classes. In addition, four in-depth interviews were conducted to capture innovative practices in clinical activities in emerging areas.
Diagnostic; Health Care; Medical Device; Orthopaedics; Medical
Abbott Vascular; Medrad; Medtronic; Boston Scientific; BARD; Zimmer; St. Jude Medical; Smith & Nephew; Stryker; Teleflex; Covidien