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Strategic Clinical Sourcing: Managing Costs and CROs
Cutting Edge Information, Aug 2009, Pages: 166
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
Product samples
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