Clinical Affairs Excellence: Benchmarking Clinical Trial Strategies for Pharmaceutical Success in a Global Marketplace

However, there are still questions around the cost, acceptability, quality and pitfalls of conducting clinical trials in emerging regions.

Best Practices®, LLC conducted primary research to inform clinical affairs leaders at pharmaceutical companies on emerging approaches to staffing, outsourcing and managing clinical trials outside of the European and U.S. regions.

Critical outsourcing questions addressed in this survey include:

• What are the regions where pharmaceutical 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?

Study Snapshot

Research participants included 7 executives and managers from 6 pharmaceutical companies across a wide variety of therapeutic areas and product classes. In addition, four executive interviews were conducted to collect qualitative insights.

Key Findings

The pharma segment’s mean clinical staffing was 34% in-house, 60% outsourced and 6% offshore, on average.

• The pharma segment outsourced a majority of all of the 7 key clinical activities studied.
• Eighty-three percent of pharma participants think the number of trials in emerging areas will increase in the next 2-3 years. A majority of pharma participants (67%) think offshore and outsource staffing will increase in the next 2-3 years.