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

ID: POP-239


Features:

25 Info Graphics

52 Data Graphics

250+ Metrics

9 Narratives


Pages: 82


Published: Pre-2014


Delivery Format: Shipped


 

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  • STUDY OVERVIEW
  • BENCHMARK CLASS
  • STUDY SNAPSHOT
  • KEY FINDINGS
  • VIEW TOC AND LIST OF EXHIBITS
In the face of cost and regulatory pressures, clinical programs at pharmaceutical organizations have looked 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, 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?

This report will inform Clinical Affairs leaders on these questions and others regarding staffing, outsourcing and managing clinical trials outside of the U.S.

Industries Profiled:
Health Care; Pharmaceutical; Diagnostic; Biotech; Medical Device


Companies Profiled:
Eisai; Abbott; Daiichi Sankyo; Merck Serono; CSL Behring; Roche

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.
Table of Contents

I.Executive Brief, Framework for Clinical, Preparing Clinical, p.2-3
II.Executive Summary
§Business Issue and Project Blueprint, p.6-7
§Participants, p.8
§Key Findings, p.9-12
III.Outside-U.S. Clinical Trial Overview and Insights, p.13-17
IV.Clinical Affairs Budget and FTEs, p. 18-25
V.Clinical Affairs Presence Around the World, p.26-30
VI.Cost and Quality of Outside-U.S. Trials and Outsourcing, p.31-37
VII.Outsourcing Levels for Key Clinical Activities, p.38-47
VIII.Vendor Selection and Outsourcing Attributes, p.48-54
IX.CRA, CRM, and CRD Competencies & Outsourcing Levels, p. 55-64
X.Clinical Affairs Organizational Fit, p.65-72
XI.Outsourcing Success Factors and Pitfalls, p. 73-75
XII.Trends and Directions for Outside-U.S. Trials & Outsourcing, p.76-78
XIII.Appendix, p. 79-81
XIV.About Best Practices, LLC, p.82