New Report "Clinical Outsourcing Strategy: Selecting Partners and Managing Relationships" available through Aarkstore Enterprise
10/27/2009

A clinical research organization (CRO) can provide flexibility and expertise to trial sponsors, complementing companies' core competencies.

Online PR News – 27-October-2009 – – 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 CRO’s 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
Selection, by Phase 65

Figure 2.20: Number of CROs That Make the Final Cut, by Phase 66

Figure 2.21: Weeks Elapsed From Final CRO/Vendor Selection to Project Kick-off, by
Phase 67

Figure 2.22: Percentage of Respondents Happy with Amount of Time Proposal Process
Takes 68

Figure 2.23: Time Spent Negotiating Contracts with CROs/Vendors, in Days 69
Managing CRO Relationships
Top Three Questions To Ask When Managing CROs

Figure 3.1: Performance Tracking and Accountability (Company E) 73

Figure 3.2: Clinical Trial Management Issues (Company E) 74

Figure 3.3: Executives Involved In Negotiating Contracts with CROs/Vendors 76
CRO Contract Negotiation

Figure 3.4: Number of Days Spent Negotiating Agreements with Preferred Vendors,
by Phase 77

Figure 3.5: Number of Days Spent Negotiating Agreements with Non-Preferred
Vendors, by Phase 78

Figure 3.6: Additional Time Spent Negotiating Contracts with Non-Preferred Vendors,
by Phase 79
Finding Payment Structures that Work

Figure 3.7: Executives Involved In Day-to-Day Oversight of CRO/Vendor’s Work 86

Figure 3.8: Management of Future Contracts with a Problematic Vendor (Company E) 89

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