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In the face of cost and regulatory pressures, clinical programs at medical device organizations have looked to less expensive and regulated areas of the world to perform clinical trial activities. Emerging markets are also fast-growing regions that present future growth opportunities for organizations that have seen sales growth slow in mature markets.
However, there are still questions around the cost, acceptability, quality and pitfalls of conducting clinical trials in emerging regions.
Best Practices®, LLC conducted primary research to inform clinical affairs leaders at medical device companies on emerging approaches to staffing, outsourcing and managing clinical trials outside of the European and U.S. regions.
Critical outsourcing questions addressed in this survey include:
What are the regions where medical device companies are conducting clinical trials and the percent of patients recruited annually from these regions?
Which clinical trial activities are best suited for outsourcing?
What is the appropriate staffing mix (in-house and outsourced) for clinical trials?
What are the most important competencies for clinical research associates, managers, and directors?
Table of Contents
Business Issue and Project Blueprint, p.5-7
Key Findings, p.10-14
Outside-U.S. Clinical Trial Overview and Insights, p.15-21
Clinical Affairs Budget and FTEs, p. 22-31
Clinical Affairs Presence Around the World, p.32-37
Cost and Quality of Outside-U.S. Trials and Outsourcing, p.38-45
Outsourcing Levels for Key Clinical Activities, p.46-55
Vendor Selection and Outsourcing Attributes, p.56-62
CRA, CRM, and CRD Competencies & Outsourcing Levels, p. 63-72
Clinical Affairs Organizational Fit, p.73-80
Outsourcing Success Factors and Pitfalls, p. 81-85
Trends and Directions for Outside-U.S. Trials & Outsourcing, p.86-88
Appendix, p. 89-94
About Best Practices, LLC, p.95