Study analyzes factors associated with outsourcing clinical trial activities

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.

But to ensure their expansion into emerging markets, device companies will have to conduct more clinical activities in these high-growth countries so they can market their new products there. While some of the largest device companies have opened or announced plans to locate large research facilities in places like China and India, other organizations are using CROs or establishing small beach-head offices and using local resources.

Outsourcing is one of the tactics clinical leaders are using to expand their clinical programs into emerging markets. To help clinical leadership evaluate their organization's approach to outsourcing clinical activities, research and consulting leader Best Practices, LLC conducted a primary research study that analyzes factors associated with outsourcing clinical trial activities, such as cost, staffing, and quality.

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 research objectives addressed in this study include:

• Determine the regions where medical device organizations conduct clinical trials and percent of patients recruited annually from each region
• Identify which Clinical Affairs activities are best suited to be outsourced or kept in-house
• Gauge what the experience of peer device organizations has been relative to the cost of outsourcing clinical trial activities
• Rate the value of benefits associated with outsourcing clinical trial activities 

The research found there is wide variance in the extent that medical device organizations have established clinical offices in emerging markets. But there appears to be consensus that if you have a clinical office or facility, you need to have company managers/leaders located there to guide clinical efforts.

"If your organization can support it, I'm a firm believer that having somebody on the ground is much more efficient operationally than trying to manage it remotely. But there's a cost benefit there or a cost that comes with having an infrastructure in those areas and it really would depend on the size of the company and the volume of work that they could do," said a clinical affairs director who participated in the study.

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/rr1232.htm.

SOURCE Best Practices, LLC