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Clinical programs at pharmaceutical organizations are increasingly looking to less expensive and regulated areas of the world to perform clinical trial activities. A parallel consideration is the use of outsourcing for clinical activities in emerging markets.
However, there are still questions around the cost, quality and pitfalls of conducting clinical trials in emerging regions and using outsourcing in those regions.
Best Practices®, LLC conducted this study to inform clinical affairs leaders at pharmaceutical companies on benchmarks around outsourcing attributes, CRA, CRM and CRD competencies and outsourcing levels for those functions, clinical affairs structure, and outsourcing trends. In addition, the study presents outsourcing success factors and pitfalls from participants' qualitative responses.
This report will inform Clinical Affairs leaders on these questions and others regarding outsourcing and managing clinical trials outside of the U.S.
- Vendor Selection and Outsourcing Attributes
- CRA, CRM and CRD Competencies and Outsourcing Levels
- Clinical Affairs Organizational Fit
- Outsourcing Success Factors and Pitfalls
- Outsourcing Trends and Directions
SAMPLE KEY FINDINGS
- Capabilities that are best predictors for vendor quality
- Rating of outsourcing benefits for clinical affairs
- Rating of competencies most important when hiring CRAs, CRMs and CRDs
- Percentage of In-sourced, Offshored and Outsourced CRAs, CRMs, and CRDs
- Where does Clinical Affairs reside from a reporting perspective
- Levels of management between Clinical Affairs head and CEO
- Anticipated Clinical Affairs trend area changes in the next three years
- Predictors for Selecting Outsource Vendor: Pharma participants felt that the best quality predictor of an outsourcing vendor was the experience of its staff. The vendor’s track record in the target geography and its staff turn-over rate also were viewed as valuable indicators.
- CRA, CRM and CRD Outsourcing Levels: On average, a majority - 66 percent - of pharma participants’ Clinical Research Associates are outsourced. On average, pharma participants also outsource a majority - 60 percent - of their Clinical Research Managers. In contrast to CRAs and CRMs, pharma participants on average keep 78 percent of their Clinical Research Directors in-house. The importance of the function in managing trials is likely the reason so many CRDs are kept in-house. .
Seven participants from six pharmaceutical companies participated. The study attracted a strong group of experienced pharmaceutical Clinical Affairs executives. Two were at the vice president level and five were at the director level. In addition, four in-depth interviews were conducted to capture innovative practices in clinical activities in emerging areas.