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市場調查報告書
臨床委外戰略：合作對象選擇與關係管理
Strategic Clinical Sourcing: Managing Costs and CROs
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臨床委外戰略：合作對象選擇與關係管理 是由出版商Cutting Edge Information在2009年04月所出版的。
這份英文市場調查報告書包含166 Pages 價格從美金5995起跳。
此報告書彙整了臨床上委外戰略制定時的重點要素、受託臨床實驗機關（CRO）的選擇與排行上的廠商選擇，還有風險與益處、CRO選擇程序的合理化等。報告書之內容摘要如下所示。
摘要
- 企業簡介
- 調查方法與定義
- 臨床委外：成功的5個原則
臨床委外戰略
- 制定委外戰略時應詢問的3個問題
- 臨床開發能力評價
- 戰略性課題：患者招募的委外
受託臨床實驗機關（CRO）選擇與契約交涉
- 對CRO候補應詢問的3個問題
- CRO基準的重要性
- CRO等級排定
- 提案提出程序管理
與CRO的關係管理
- CRO管理時應詢問的3個問題
- CRO契約交涉
- 探求具功能的支付型態
Abstract
Perfect the CRO selection and management process - and guarantee trial success
Strategic Clinical Sourcing: Managing Costs and CROs aims to improve your
company' s clinical outsourcing decision-making during every step of the
process - from strategy setting to daily relationship management. Trial cost
and timeline benchmarks - coupled with input from leading executives - will
show trial teams how to efficiently and effectively manage outsourced trials.
Establish the tone for success with a proactive strategy
Trials will run into obstacles - it' s a fact. But attention to detail when
assessing clinical needs and anticipating problems goes a long way toward
desired outcomes. The report examines the groups and individuals who set
strategy, the breakdown of tasks outsourced to vendors and the treatment of
patient recruiting, a recurring challenge for trial teams.
Learn what other companies pay for outsourced trial activities
Clinical vendors' expertise provides great opportunities for cost savings. Be
confident in knowing that you are paying acceptable rates - benchmark against
examples of trial budgets and unit hour costs for nine key roles. Also, data
on peak-level headcounts for specific trial roles will help your company zero
in on staffing needs.
Find the CRO best suited to your project and negotiate the contract
Clinical outcomes could ultimately bring lucrative results, so it' s important
to choose a CRO wisely. Our study details a wide range of CRO traits and
includes performance rankings of actual CROs. Beyond vendor selection, we
reveal timeline data and strategies for improving the proposal review process.
Resolve conflicts quickly and ensure top-quality performance
Effectively managing trial progress, vendor relationships and development
costs requires attention to both qualitative and quantitative performance
indicators. Using data benchmarks and best practices, this chapter explores
common complications that hinder trials, and it provides preventative
solutions. Key topics include contract negotiation, vendor compensation, CRO
performance and conflict resolution.
Table of Contents
11 Executive Summary
- 16 Profiled Companies
- 17 Methodology and Definitions
- 18 Clinical Trial Outsourcing: Five Principles for Success
27 Clinical Outsourcing Strategy
- 28 Top Three Questions to Ask When Setting Outsourcing Strategy
- 30 Evaluation of Core Clinical Development Capabilities
- 39 A Strategic Bottleneck: Outsourcing Patient Recruitment
47 Outsourced Trial Cost Management
- 48 Top Three Questions to Ask When Managing Resources in Clinical
Outsourcing:
- 49 Total Trial Cost
- 53 Trial Site Location
- 61 Role and Unit Cost Breakdowns
- 65 Exploration of Individual Trial Roles
101 CRO Selection and Contract Management
- 102 Top Three Questions to Ask a CRO Candidate
- 107 Importance of CRO Criteria
- 118 CRO Ratings
- 123 Managing the Proposal Submission Process
133 Managing CROs and Monitoring Trial Metrics
- 134 Top Three Questions To Ask When Managing CROs
- 138 Current Critical Challenges
- 141 Best Practices in Problem-Solving and Conflict Resolution
- 152 Non-Monetary Trial Metrics
- 164 Proposal Standardization
CHARTS AND GRAPHICS
Executive Summary
Clinical Trial Outsourcing: Five Principles for Success
- 22 Figure E.1: Importance of CRO' s Ability to Meet Deadlines, by Company
Clinical Outsourcing Strategy
- Evaluation of Core Clinical Development Capabilities
- 31 Figure 1.1: Executives Involved in Determining Which Activities Will Be
Outsourced
- 33 Figure 1.2: Percentage of Companies Outsourcing Activities in a
Majority of Trials
- 34 Figure 1.3: Percentage of Companies Outsourcing Specific Activities in
at Least One Trial by Contract Type
Outsourced Trial Cost Management
- Total Trial Cost
- 49 Figure 2.1: Phase II Trial Costs
- 50 Figure 2.2: Phase III Trial Costs
- 50 Figure 2.3: Phase IV Trial Costs
- Trial Site Location
- 54 Figure 2.4: Trial Locations
- 55 Figure 2.5: Locations of Trials: Asia/Pacific
- 56 Figure 2.6: Locations of Trials: Europe
- 57 Figure 2.7: Locations of Trials: Americas
- 58 Figure 2.8: Locations of Trials: Middle East/Africa
- Role and Unit Cost Breakdowns
- 62 Figure 2.9: Average Outsourced Cost Per Unit Hour By Role/Activity
- 63 Figure 2.10: Average Peak In-House FTEs
- 63 Figure 2.11: Average Peak Outsourced FTEs
- Exploration of Individual Trial Roles
- 66 Figure 2.12: Outsourcing of Trial Management
- 66 Figure 2.13: Outsourcing of CRAs/Trial Monitoring
- 68 Figure 2.14: Company D CRA Reporting Structure
- 69 Figure 2.15: Cost Per Unit Hour: CRAs/Monitors
- 70 Figure 2.16: Outsourced CRA/Monitor Costs as a Percentage of Total
Trial Costs
- 71 Figure 2.17: Peak In-House FTEs: CRAs/Monitors
- 71 Figure 2.18: Peak Outsourced FTEs: CRAs/Monitors
- 72 Figure 2.19: Cost Per Unit Hour: Trial Managers
- 73 Figure 2.20: Outsourced Clinical Trial Managment Costs as a Percentage
of Total Trial Costs
- 74 Figure 2.21: Peak In-House FTEs: Trial Managers
- 74 Figure 2.22: Peak Outsourced FTEs: Trial Managers
- 75 Figure 2.23: Outsourcing of Data Management
- 76 Figure 2.24: Cost Per Unit Hour: Data Management
- 77 Figure 2.25: Peak In-House FTEs: Data Management
- 77 Figure 2.26: Peak Outsourced FTEs: Data Management
- 78 Figure 2.27: Outsourcing of Biostatistics/Bioanalytics
- 79 Figure 2.28: Cost Per Unit Hour: Biostatistics/Bioanalytics
- 80 Figure 2.29: Peak In-House FTEs: Biostatistics/Bioanalytics
- 80 Figure 2.30: Peak Out-sourced FTEs: Biostatistics/Bioanalytics
- 81 Figure 2.31: Outsourcing of Patient Recruitment
- 83 Figure 2.32: Cost Per Unit Hour: Patient Recruiters
- 83 Figure 2.33: Peak In-House FTEs: Patient Recruiters
- 84 Figure 2.34: Peak Outsourced FTEs: Patient Recruiters
- 85 Figure 2.35: Outsourcing of Clinical Trial Supplies
- 86 Figure 2.36: Cost Per Unit Hour: Clinical Trial Supplies
- 87 Figure 2.37: Peak In-House FTEs: Clinical Trial Supplies
- 87 Figure 2.38: Peak Outsourced FTEs: Clinical Trial Supplies
- 88 Figure 2.39: Outsourcing of Medical Writing
- 89 Figure 2.40: Cost Per Unit Hour: Medical Writers
- 90 Figure 2.41: Peak In-House FTEs: Medical Writers
- 90 Figure 2.42: Peak Outsourced FTEs: Medical Writers
- 91 Figure 2.43: Outsourcing of Regulatory
- 92 Figure 2.44: Cost Per Unit Hour: Regulatory
- 93 Figure 2.45: Peak In-House FTEs: Regulatory
- 94 Figure 2.46: Peak Outsourced FTEs: Regulatory
- 95 Figure 2.47: Outsourcing of Senior Level Oversight
- 97 Figure 2.48: Cost Per Unit Hour: Senior Level Oversight
- 98 Figure 2.49: Peak In-House FTEs: Senior Level Oversight
- 98 Figure 2.50: Peak Outsourced FTEs: Senior Level Oversight
CRO Selection and Contract Management
- Top Three Questions to Ask a CRO Candidate
- 102 Figure 3.1: Importance of CRO' s Ability to Meet Deadlines, by Company
- 104 Figure 3.2: Importance of Company Size and Geographical Reach when
Selecting CROs
- 106 Figure 3.3: Executives Involved in Selecting the CROs/Vendors
- Importance of CRO Criteria
- 107 Figure 3.4: Importance of Overall Cost and Preferred Status when
Selecting CROs
- 110 Figure 3.5: Importance of Company Size and Geographical Reach when
Selecting CROs
- 113 Figure 3.6: Importance of Work Quality When Selecting CROs
- 114 Figure 3.7: Importance of Relationship Management When Selecting CROs
- 115 Figure 3.8: Importance of Experience with Similar Products When
Selecting CROs
- 117 Figure 3.9: Other Considerations When Selecting CROs
- CRO Ratings
- 118 Figure 3.10: Performance Ratings for Quintiles
- 119 Figure 3.11: Performance Ratings for PPD
- 120 Figure 3.12: Performance Ratings for Covance
- 121 Figure 3.13: Performance Ratings for Parexel
- 122 Figure 3.14: Performance Ratings for Icon
- 123 Figure 3.15: Number of CROs Receiving RFPs, by Phase
- Managing the Proposal Submission Process
- 124 Figure 3.16: Weeks Elapsed From RFPs Sent to Proposal Submission
Deadline, by Phase
- 125 Figure 3.17: Number of CROs Submitting Proposals, by Phase
- 126 Figure 3.18: Percentage of Respondents Happy with Number of Proposals
Received
- 127 Figure 3.19: Weeks Elapsed From Proposal Submission Deadline to Final
CRO/Vendor Selection, by Phase
- 128 Figure 3.20: Number of CROs That Make the Final Cut, by Phase 128
- 129 Figure 3.21: Weeks Elapsed From Final CRO/Vendor Selection to Project
Kick-off, by Phase
- 130 Figure 3.22: Percentage of Respondents Happy with Amount of Time
Proposal Process Takes
- 131 Figure 3.23: Time Spent Negotiating Contracts with CROs/Vendors, in
Days
Managing CROs and Monitoring Trial Metrics
- Top Three Questions To Ask When Managing CROs
- 135 Figure 4.1: Performance Tracking and Accountability (Company E)
- 136 Figure 4.2: Clinical Trial Management Issues (Company E)
- Best Practices in Problem- Solving and Conflict Resolution
- 146 Figure 4.3: Executives Involved in Day-to-Day Oversight of
CRO/Vendor' s Work
- 149 Figure 4.4: Management of Future Contracts with a Problematic Vendor
(Company E)
- Non-Monetary Trial Metrics
- 153 Figure 4.5: Number of Days Spent Negotiating Agreements with Preferred
Vendors, by Phase
- 155 Figure 4.6: Number of Days Spent Negotiating Agreements with
Non-Preferred Vendors, by Phase
- 155 Figure 4.7: Additional Time Spent Negotiating Contracts with
Non-Preferred Vendors, by Phase
- 155 Figure 4.8: Executives Involved In Negotiating Contracts with
CROs/Vendors
- 156 Figure 4.9: Percentage of Reported Trials by Phase
- 157 Figure 4.10: Trial Disease State
- 159 Figure 4.11: Length of Time from Protocol Finalization to Report
Completion (in Months)
- 159 Figure 4.12: Length of Time from Protocol Finalization to First
Patient First Visit (in Months)
- 160 Figure 4.13: Length of Time from First Patient First Visit to Last
Patient Last Visit (in Months)
- 161 Figure 4.14: Length of Time from Last Patient Last Visit to Clinical
Trial Report (in Months)
- 162 Figure 4.15: Target Patient Enrollment
- 163 Figure 4.16: Effect of Target Patient Enrollment on Months Taken to
Collect Data
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