A centralized resourcing model within clinical research organizations can provide efficiencies in resource management. It involves having a central point of contact to manage the resource assignment, deployment, and utilization across programs. Key ingredients for success include regular communication, standardized processes for resource requests and tracking, and reliable tools for resource planning and metrics. This model allows resources to be strategically allocated, utilization to be maximized through short-term assignments, and proactive planning to improve cost and time efficiencies.
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Centralized Resourcing Model for Clinical Trials
1. A Centralized Resourcing
Model: A Recipe for Success in
Resource Management within
the CRO Arena
Cindi G. Stout
Director, CTM Resourcing
Premier Research Group
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3. Topics
• What is a Centralized Resourcing Model?
– definition, goals
• What is required to support this resourcing
model?
– communication, standardization, tools/reports
• How can this resourcing model gain
efficiencies in the trial management?
– scenarios
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Washington, DC - 2010 3
4. Centralized Resourcing Model
• Central point of contact managing process
– Critical for assignment, deployment, and utilization of
clinical staff across programs
• Regular communication between resource
management and internal clients
• Reliable and consistent process for filling resource
need and tracking to completion
• Collaborative environment towards shared goal
• Reliable tools and reports
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Washington, DC - 2010 4
5. Key Ingredients
• Communication
– With whom?
• business development, internal clients, and external
clients (as appropriate)
– Why?
• gain intelligence on new wins and/or high probables
• gain intelligence on timeline shifts, delays, upcoming
milestones, resource gaps and expectations
• ensure all have same goal and are on same page
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Washington, DC - 2010 5
6. Key Ingredients
• Standardization
– Central point of contact for action
– Process for making resource requests
– Resource definitions (i.e. FTE = ? billable hours)
– Allows for generation of performance metrics
– Reduces internal conflict
– Enables detailed tracking process of dynamic
data
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Washington, DC - 2010 6
7. Key Ingredients
• Tools and Reports
– Excel and/or programmed databases
– Track assignments, actual and projected hours,
utilization metrics
– Trial activity is dynamic
• Must be able to update as often as changes occur
• Again, we go back to communication being the first
key ingredient!!!
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Washington, DC - 2010 7
8. Key Ingredients
• Tools and Reports
– Confirms resources are allocated appropriately
– Ensures resources are meeting utilization
targets
– Allows for proactive planning for resource
requirements
– Strikes work/life balance to increase resource
retention, client satisfaction and repeat business
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Washington, DC - 2010 8
9. Efficiencies in Clinical Operations
• Examples of uses of short term downtime
– Site Qualification Visits for unassigned trial
– Data query resolution support
– In-house file reviews
– Document generation
– Regulatory document package review
• Ensures utilization target is maintained
• Ensures existing staff are fully engaged
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10. Efficiencies in Clinical Operations
• Managing turnover within resource model
– First assess what remaining team can absorb
– Then assess existing open resources for
remaining gap
– Finally, initiate external resource recruitment
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11. Sample Forecasting Within Model
CRA Staffing for ABC Pharma Program
120
100
80
60
FTE's
40
20
0
Study 1 Study 2 Study 3 Study 4 Study 5 Study 6 Study 7
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12. Strategic Planning Within Model
Protocol 2009 2010
May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May
Study 1 1 2 2 2 1 1 1
Study 2 1 2 2 2 1 1 1
Study 3 1 2 2 2 1 1 1
Study 4 2 4 5 5 3 2 1
Study 5 1 2 2 1 1 1
Study 6 3 7 7 7 3 3 2
Study 7 1 1 1 1 1 1
Total 1 5 9 13 16 14 14 9 7 5 2 2 1
Internal 1 5 9 11 14 10 10 8 6 5 2 2 1
New Hire 0 0 0 2 2 4 4 1 1 0 0 0 0
Start-up
Enrollment
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Washington, DC - 2010 12
13. Conclusions
• Benefits of a centralized resourcing model
– Central point of contact responsible for all resource
management
– Standard resource process and tools provides
consistency in resource management
– Efficient utilization of resources across studies/projects
• Proactive planning of resources (ramping up or
down) provides cost and time efficiencies
• Improved staff retention with appropriate level of
work assignment
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Washington, DC - 2010 13