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

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
  • 2.
    Disclaimer • The viewsand 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
  • 3.
    Topics • What isa 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
  • 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 46th Annual Meeting 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 46th Annual Meeting 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 46th Annual Meeting Washington, DC - 2010 6
  • 7.
    Key Ingredients • Toolsand 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
  • 8.
    Key Ingredients • Toolsand 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
  • 9.
    Efficiencies in ClinicalOperations • 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
  • 10.
    Efficiencies in ClinicalOperations • 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
  • 11.
    Sample Forecasting WithinModel 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
  • 12.
    Strategic Planning WithinModel 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
  • 13.
    Conclusions • Benefits ofa 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