NEW YORK, Nov. 20 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue.

Strategic Clinical Sourcing: Managing Costs and CROs

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Strategic Clinical Sourcing: Managing Costs and CROs is an in-depth look at the entire clinical outsourcing process. Our study analyzes outsourcing strategies, costs, and timelines of top pharmaceutical companies.

- Set a winning strategy: Learn how to optimize your available resources and avoid problems in key aspects like patient recruitment.

- Control costs and limit waste: Consult real-world examples of trial costs at all phases of development. Find per unit hour metrics for nine roles/positions ensure that you are paying CROs at a reasonable rate.

- Select the right vendor and negotiate a deal: Examine rankings for 25 CRO traits over six different categories.

- Manage the relationship successfully: Adapt real-company strategies to resolving conflicts and ensuring acceptable compensation structures.

Key Metrics

Strategic Clinical Sourcing: Managing Costs and CROs four chapters contain trial cost, staffing and timeline metrics. They include the following:

Chapter 1: Clinical Outsourcing Strategy

- Executives involved in determining which activities will be outsourced

- Percentage of companies outsourcing clinical trial activities

- Percentage of companies outsourcing clinical trial activities by type

Chapter 2: Outsourced Trial Cost Management

- Percentage of companies outsourcing position/roles, including trial managers, CRAs and monitors, data management, patient recruiters, clinical trial supplies and biostatistics

- Total trial costs by development phase II, III, and IV

- Staffing and cost per unit hour metrics are included for nine roles/ positions:

-- CRA/monitoring

-- Trial management

-- Data management

-- Biostatistics/bioanalytics

-- Patient recruitment

-- Clinical trial supplies

-- Medical writing

-- Regulatory

-- Senior level oversight

Prevalence of trials taking place in major regions worldwide: Asia/Pacific, Europe, Americas

Chapter 3: CRO Selection and Contract Negotiation

CRO Criteria: Importance of

- a CRO's ability to meet deadlines, by company

- company size and geographical reach when selecting CROs

- overall cost and preferred status when selecting CROs

- work quality when selecting CROs

- relationship management when selecting CROs

- experience with similar products when selecting CROs

- other considerations: turnover rate, knowledge of regulatory concerns and intellectual property

CRO Performance Ratings

On a scale of 1 to 5 -- with 5 being best -- study participants rate actual CROs on:

- price

- reach

- work quality

- therapeutic area/drug experience

- relationship management

CRO Selection Process Timeline Metrics:

- Number of CROs receiving RFPs

- Weeks elapsed from RFPs sent to proposal submission deadline

- Number of CROs submitting proposals, by phase

- Weeks elapsed from proposal deadline to final CRO/vendor selection, by phase

- Number of CROs that make the final cut

- Percentage of respondents happy with amount of time proposal process takes

- Time spent negotiating contracts with CROs/vendors, in days

Chapter 4: Managing CROs and Monitoring Trial Metrics

Relationship Management

- Performance tracking and accountability (reporting structure of a surveyed company)

- Clinical trial management issues (surveyed company example)

- Executives involved in negotiating contracts with CROs/vendors

- Number of days spent negotiating agreements with preferred vendors versus non-preferred vendors

- Executives involved in day-to-day oversight of CRO/vendor's work

- Management of future contracts with a problematic vendors

Timeline metrics

- Percentage of reported trials by phase

- Trial disease state

- Length of time from protocol finalization to first patient's first visit (in months)

- Length of time from first patient visit to last patient's last visit

- Length of time from last patient visit to clinical trial report

- Target patient enrollment

- Effect of target patient enrollment on months taken to collect data

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:

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 Management 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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Strategic Clinical Sourcing: Managing Costs and CROs

http://www.reportlinker.com/p0164999/Strategic-Clinical-Sourcing-Managing-Costs-and-CROs.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=prnewswire

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