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Clinical programs at medical device 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 medical device 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
- On average, 46 percent of device participants have Clinical Affairs set up as a stand-alone division or business unit.
- A majority of clinical leaders in the device segment (64%) believe in the coming 2-3 years more trials will be conducted in Asia-Pacific and emerging markets/high growth BRIC countries. Correspondingly, 77 % believe outsource staffing will increase over the same period and 69% believe offshore staffing will similarly increase. .
Research participants included 13 executives and managers from 11 medical device companies across a wide variety of therapeutic areas and product classes. In addition, four in-depth interviews were conducted to capture innovative practices in clinical activities in emerging areas.