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Centralized Resourcing Model for Clinical Trials
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Centralized Resourcing Model for Clinical Trials

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The clinical research arena is a fast-paced and dynamic entity where it is a standard expectation that a service provider be able to prioritize, re-prioritize, and successfully deliver amidst ever ...

The clinical research arena is a fast-paced and dynamic entity where it is a standard expectation that a service provider be able to prioritize, re-prioritize, and successfully deliver amidst ever changing timelines while operating in an efficient manner. Though this may sound challenging, it is achievable through the use a centralized resourcing model, supported by valuable tools, enabling a provider to mobilize the appropriate resources at the appropriate time while maintaining budget and utilization targets. Through involvement in this session, participants will become familiar with the key components to the structure of a centralized resourcing model as well as the tools that are paramount to its success. Participants will also learn of several sample scenarios in which they can realize time and cost efficiencies from such a model in all phases of the study lifecycle.

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    Centralized Resourcing Model for Clinical Trials Centralized Resourcing Model for Clinical Trials Presentation Transcript

    • A Centralized Resourcing Model: A Recipe for Success in Resource Management within the CRO Arena Cindi G. Stout Director, CTM Resourcing Premier Research Group
    • Disclaimer • The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. (“DIA”), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated. • These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, DIA and DIA logo are registered trademarks or trademarks of Drug Information Association Inc. All other trademarks are the property of their respective owners. 46th Annual Meeting Washington, DC - 2010 2
    • 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 46th Annual Meeting Washington, DC - 2010 3
    • 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 46th Annual Meeting Washington, DC - 2010 4
    • 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 46th Annual Meeting Washington, DC - 2010 5
    • 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 46th Annual Meeting Washington, DC - 2010 6
    • 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!!! 46th Annual Meeting Washington, DC - 2010 7
    • 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 46th Annual Meeting Washington, DC - 2010 8
    • 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 46th Annual Meeting Washington, DC - 2010 9
    • 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 46th Annual Meeting Washington, DC - 2010 10
    • 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 46th Annual Meeting Washington, DC - 2010 11
    • 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 46th Annual Meeting Washington, DC - 2010 12
    • 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 46th Annual Meeting Washington, DC - 2010 13