This document summarizes the findings of a benchmarking study conducted by Best Practices, LLC on clinical trial strategies for medical device companies. Key findings include:
- The average medical device company in the study had $3.8 billion in annual revenue and spent $39 million (1.1% of revenue) on clinical affairs.
- Most device companies conducted the majority (72%) of clinical trials in-house, with 22% outsourced and 4% offshore. Pharma companies outsourced more activities.
- Regulators had extensive questions about outside the US trial data for 46% of device companies and 38% felt data led to extensive regulatory conversations.
- Device companies did not out
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Benchmarking Clinical Trial Strategies
1. BEST PRACTICES,
®
LLC
Best Practices, LLC Strategic Benchmarking Research
Clinical Affairs Excellence:
Benchmarking Clinical Trial Strategies to Ensure
Medical Device Success in a Global Marketplace
2. BEST PRACTICES,
®
LLC
TABLE OF CONTENTS
I. Executive Summary
Business Issue and Project Blueprint, p.5-7
Participants, p.8-9
Key Findings, p.10-14
II. Outside-U.S. Clinical Trial Overview and Insights, p.15-21
III. Clinical Affairs Budget and FTEs, p. 22-31
IV. Clinical Affairs Presence Around the World, p.32-37
V. Cost and Quality of Outside-U.S. Trials and Outsourcing, p.38-45
VI. Outsourcing Levels for Key Clinical Activities, p.46-55
VII. Vendor Selection and Outsourcing Attributes, p.56-62
VIII. CRA, CRM, and CRD Competencies & Outsourcing Levels, p. 63-72
IX. Clinical Affairs Organizational Fit, p.73-80
X. Outsourcing Success Factors and Pitfalls, p. 81-85
XI. Trends and Directions for Outside-U.S. Trials & Outsourcing, p.86-88
XII. Appendix, p. 89-94
XIII. About Best Practices, LLC, p.95
16. BEST PRACTICES,
®
LLC
Best Practices, LLC is a research and consulting firm that conducts work
based on the simple yet profound principle that organizations can chart a
course to superior economic performance by studying the best business
practices, operating tactics and winning strategies of world-class
companies.
Best Practices, LLC
6350 Quadrangle Drive, Suite 200, Chapel Hill, NC 27517
919-403-0251
best@best-in-class.com
www.best-in-class.com
About Best Practices, LLC