Clinical Outsourcing Strategy: Selecting Partners And Managing Relationships
Outsourcing can be a cost-efficient means to achieve clinical objectives and ensure a drug's successful path through development
. A clinical research organization (CRO) can provide flexibility and expertise to trial sponsors, complementing companies' core competencies. But CRO management will drive up trial costs, delay a drug's time to market, or at worst, lead to a trial cancellation and threaten a drug's future.
Table of Contents :
Executive Summary
Profiled Companies
Methodology and Definitions
Clinical Trial Outsourcing: Five Principles for Success
Clinical Outsourcing Strategy
Top Three Questions to Ask When Setting Outsourcing Strategy
Evaluation of Core Clinical Development Capabilities
A Strategic Bottleneck: Outsourcing Patient Recruitment
CRO Selection and Contract Negotiation
Top Three Questions to Ask a CRO Candidate
Importance of CRO Criteria
CRO Ratings
Managing the Proposal Submission Process
Managing CRO Relationships
Top Three Questions To Ask When Managing CROs
CRO Contract Negotiation
Finding Payment Structures that Work
Executive Summary
Clinical Outsourcing Strategy
Evaluation of Core Clinical Development Capabilities
Figure 1.1: Executives Involved in Determining Which Activities Will Be Outsourced 23
Figure 1.2: Percentage of Companies Outsourcing Activities in a Majority of Trials 25
Figure 1.3: Percentage of Companies Outsourcing Specific Activities in at Least One
Trial by Contract Type 26
CRO Selection and Contract Negotiation
Figure 2.1: Importance of CROs Ability to Meet Deadlines, by Company 40
Top Three Questions to Ask a CRO Candidate
Figure 2.2: Importance of Company Size and Geographical Reach when Selecting
CROs 42
Figure 2.3: Executives Involved In Selecting the CROs/Vendors 44
Figure 2.4: Importance of Overall Cost and Preferred Status when Selecting CROs 45
Importance of CRO Criteria
Figure 2.5: Importance of Company Size and Geographical Reach when Selecting
CROs 48
Figure 2.6: Importance of Work Quality when selecting CROs 51
Figure 2.7: Importance of Relationship Management when Selecting CROs 52
Figure 2.8: Importance of Experience with Similar Products when Selecting CROs 53
Figure 2.9: Other Considerations when Selecting CROs 55
Figure 2.10: Performance Ratings for Quintiles 56
CRO Ratings
Figure 2.11: Performance Ratings for PPD 57
Figure 2.12: Performance Ratings for Covance 58
CHARTS AND GRAPHICS
Figure 2.13: Performance Ratings for Parexel 59
Figure 2.14: Performance Ratings for Icon 60
Figure 2.15: Number of CROs Receiving RFPs, by Phase 61
Managing the Proposal Submission Process
Figure 2.16: Weeks Elapsed From RFPs Sent to Proposal Submission Deadline, by Phase 62
Figure 2.17: Number of CROs Submitting Proposals, by Phase 63
Figure 2.18: Percentage of Respondents Happy With Number of Proposals Received 64
Figure 2.19: Weeks Elapsed From Proposal Submission Deadline to Final CRO/Vendor