CHAPEL HILL, N.C., March 21, 2014 /PRNewswire/ -- It's no secret that the medical device sector sees emerging markets such as China and Brazil as their best opportunity for top-line growth over the next decade.
In a study by research and consulting leader Best Practices, LLC, clinical leaders spoke of using CROs to get clinical operations implemented quickly in new markets. But they emphasized that an organization needs its own staff in order to effectively establish a clinical presence.
In emerging areas of the world, it's essential to have someone with knowledge of local rules and customs to help your organization navigate the business/clinical environment, according to medical device leaders interviewed as part of the study. That means hiring clinical research associates, managers or directors who are natives, they said.
The study, 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.
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 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.
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, click on the following link: http://www3.best-in-class.com/rr1277.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