Examining the User of Emerging Markets, Outsourcing

Medical device organizations are experiencing two dynamics in mature markets like North America and Europe: Clinical costs are continuing to rise and sales are either growing negligibly or not at all.

In emerging markets, meanwhile, device organizations are experiencing lower clinical costs and rapidly rising sales. While mature markets still represent a lion's share of most device companies' sales, emerging markets represent significant cost savings and important future sales. And large countries like China and India are now requiring local clinical trials to win regulatory approvals to market products in those countries.

What this all adds up to is more medical device organizations are evaluating an expansion of their clinical programs into emerging markets to cut costs and boost sales.

A study from research and consulting firm Best Practices, LLC, Clinical Affairs Excellence: Benchmarking Clinical Trial Strategies to Ensure Medical Device Success in a Global Marketplace, delivers hard-to-find 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?

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.

To access the full report or to download a complimentary summary containing insights found in this report, click on the following link: http://www3.best-in-class.com/rr1148.htm.