CHAPEL HILL, N.C., Sept. 7, 2012 /PRNewswire/ -- Medical device organizations with a presence in emerging markets are consistently reporting double-digit revenue growth in their quarterly and annual reports. As part of their expansion into emerging markets, device companies are conducting more and more clinical trials in these high-growth countries. Some companies are using CROs, others are establishing small beach-head offices and using local resources while some are spending tens of millions for brick-and-mortar research facilities in places like China and India.
What this all adds up to is medical device organizations need to evaluate expansion of their clinical programs into emerging markets to cut costs and boost sales. Large countries like China and India are now requiring local clinical trials to win regulatory approvals to market products in those countries.
A study from Best Practices, LLC, Clinical Affairs Excellence: Benchmarking Clinical Trial Strategies to Ensure Medical Device Success in a Global Marketplace, delivers hard-to-find external benchmarks on medical device clinical programs' presence in emerging markets, activities outsourced, staffing and budgets.
This study analyzes factors associated with outsourcing clinical trial activities – including cost, staffing and quality – to help clinical leaders evaluate their organization's approach to outsourcing relative to peers. Through the qualitative (four executive interviews were done as part of this study) and quantitative data in this study, clinical leaders can formulate a strategic approach for engaging emerging regions in clinical affairs activities.
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?
This report will inform Clinical Affairs leaders on these questions and others regarding staffing, 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 executive interviews were conducted to collect qualitative insights.
To access the full report or to download a complimentary summary, click on the following link: http://www3.best-in-class.com/rr1176.htm.
ABOUT BEST PRACTICES, LLC
Best Practices, LLC is a leading benchmarking, consulting and advisory services firm serving biopharmaceutical and medical device companies worldwide. Best Practices, LLC's clients include all the top 10 and 48 of the top 50 global healthcare companies. The firm conducts primary research and consulting using its comprehensive proprietary benchmarking tools and analysis. The operational insights, findings and analysis form the basis for our Benchmarking Reports, databases and advisory services to support executives in commercial and R&D operations. Best Practices, LLC believes in the profound principle that organizations can chart a course to superior economic performance by studying the winning strategies of world-class companies.
SOURCE Best Practices, LLC