Business Operations Best Practices
Best Practices, LLC has conducted extensive research in the field of Business Operations. Browse through and sample our published Business Operations research in the topics below:
| |  | Clinical Affairs Excellence: Benchmarking Clinical Budgets, Staffing and Activities for Medical Device Success in a Global Marketplace  
Non-members: Click here to review a complimentary excerpt from "Clinical Affairs Excellence: Benchmarking Clinical Budgets, Staffing and Activities for Medical Device Success in a Global Marketplace"
STUDY OVERVIEW
Clinical programs at medical device organizations are increasingly looking to less expensive and regulated areas of the world to perform clinical trial activities. Emerging markets are also fast-growing regions that present future growth opportunities for organizations that have seen sales growth slow in mature markets.
However, there are still questions around the cost, quality and pitfalls of conducting clinical trials in emerging regions.
Best Practices®, LLC conducted this study to inform clinical affairs leaders at medical device companies on benchmarks around budgets, and staffing. In addition, the study presents benchmarks and insights around the current level of clinical trials in emerging areas, the cost and quality of outside-U.S. trials, and outsourcing levels for key clinical activities.
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?
This report will inform Clinical Affairs leaders on these questions and others regarding staffing, outsourcing and managing clinical trials outside of the U.S.
KEY TOPICS
Outside-U.S. Clinical Trial Overview and Insights
Clinical Affairs Budget and FTEs
Clinical Affairs Presence Around the World
Cost and Quality of Outside-U.S. Trials and Outsourcing
Outsourcing Levels for Key Clinical Activities
KEY METRICS
Company revenues and clinical affairs spend
Percentage of Clinical Affairs budget dedicated for studies
Number of FTEs in global clinical affairs organization and FTEs per $100M in revenue
Percentage of Clinical Affairs staffing working in emerging markets (BRIC)
Percentage mix of Clinical Affairs staffing in terms of in-house, outsourced and offshored
Optimal mix of U.S. and outside-U.S. trial sites/volunteers to meet FDA quality standards
Regions where conducting clinical trials and percentage of patients from each region
Experience with cost of outside U.S. trials
Regulatory authorities reaction to clinical data from outside-U.S. trials
Level of satisfaction with quality of outside-U.S. trials
Percentage of outsourcing and in-house staff used for seven key clinical activities
Rating of outsourcing suitability for seven key clinical activities
SAMPLE KEY FINDINGS
Device participants, on average, had 91 % of their trial patients in the U.S. & Europe. But an average of 6% of their patients were in Asia-Pacific and 2 % were in emerging markets.
The device segment appears to lag significantly behind pharma regarding outsourcing clinical activities. While the device segment did not outsource a majority of any of the seven key clinical activities benchmarked in this study, a parallel study found that pharma companies typically outsource a majority of all of them.
METHODOLOGY
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.
Clinical Affairs Excellence: Benchmarking Clinical Roles and Trends for Pharmaceutical Success in a Global Marketplace
Non-members: Click here to review a complimentary excerpt from "Clinical Affairs Excellence: Benchmarking Clinical Roles and Trends for Pharmaceutical Success in a Global Marketplace"
STUDY OVERVIEW
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.
KEY TOPICS
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
KEY METRICS
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
SAMPLE KEY FINDINGS
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. .
METHODOLOGY
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.
Best Practices in Health and Safety Management - Lessons Learned
This document contains a matrix with the top three lessons learned for managing staffing, roles and budgets for the health and safety function. The matrix includes responses from executives at six world-class companies.
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