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Variable Billing vs.
   Fixed-Price Models:
How Does Your Clinical Trial Stand to Gain?
 Click to edit Master title style
           Mark Shapiro, MA, MBA, CCRA, RAC
           Executive Director, Clinical Solutions
             Click to edit Master title style
                CLINIPACE WORLDWIDE


                   David Hinds, MBA
                 Global Project Director
                CLINIPACE WORLDWIDE
Technology-Amplified CRO
             Frictionless Services
          Project Management
          Site Selection and Global Study Feasibility

        Click to edit Master title style
          Clinical Monitoring and Site Management
          Data Management
          Biostatistics
          Medical Management/Monitoring
          Patient Recruitment to edit Master title style
                            Click
          Regulatory Services
           GxP Quality Assurance
          Medical Writing
          Drug/Device Safety


RIGHT-SIZEDTM CLINICAL RESEARCH SERVICES                    www.clinipace.com
Let’s get on the same page


                           Variable Billing                             Fixed-Price
      Click to edit Master title style
     Hourly   Functional Unit-
                                                                        Value-Based
      Billing                 Outsourcing                   Based
                                     Click to edit Master title style




RIGHT-SIZEDTM CLINICAL RESEARCH SERVICES                                  www.clinipace.com
So, here we are…
       CROs get paid for hours worked or tasks
       performed, not value provided
       CROs earn most of their money from high-
       volume task-level activities {the area least valued
        Click to edit Master title style
       by sponsors}
       CRO pricing is often based on costs or effort not
       value
       CROs have extensive, Master title style
                     Click to edit process-based intellectual
       property for how to conduct of the trial, but…
       Have commoditized their services and removed
       value from services in favor of units and volume

RIGHT-SIZEDTM CLINICAL RESEARCH SERVICES             www.clinipace.com
Variable billing is killing drug
       development, because it
       Misaligns interests of the CRO and client…
         By not sharing project risk with the client

        Click to edit Master title style
         By focusing on costs, not value creation
       Focuses on efforts and inputs, not results,
       which…
         Promotes a Click to edit Master title style a commodity
                      view of services as
         Penalizes technological innovation
         Does not differentiate


RIGHT-SIZEDTM CLINICAL RESEARCH SERVICES                  www.clinipace.com
THE CRO                Hourly, effort-
        Click to edit Master task-based
         STATUS               and        title style
           QUO: to edit Masterpricing leads to
                 Click        title style
                                              scope
                                           changes and
                                           change fees
RIGHT-SIZEDTM CLINICAL RESEARCH SERVICES           www.clinipace.com
6 reasons we should change the
          status quo
  1.     It   is time consuming without adding value
  2.     It   makes clients nervous
  3.     It   encourages lower productivity
  4.    Click to edit Master title style
         It   lends itself to tedious work
  5.     It   doesn't stop scope creep
  6.     It   encourages an adversarial relationship
                                     Click to edit Master title style




RIGHT-SIZEDTM CLINICAL RESEARCH SERVICES                                www.clinipace.com
Drivers that are pushing
  traditional ways of billing aside
       the recognition that hourly billing is excessive in
       difficult economic times
       a gnawing feeling that clients are poorly served
        Click to edit Master title style
       by hourly billing and the bidding practices that it
       engenders
       a shift toward building strategic relationships
       between CROsClick to edit Master title style
                       and sponsors
       the desire to mitigate risk and contain budgets.



    http://www.lifescienceleader.com/index.php?option=com_jambozine&layout=article&view=page&aid=3931

RIGHT-SIZEDTM CLINICAL RESEARCH SERVICES                                                                www.clinipace.com
WHAT ARE          Sponsors are
        Click to edit Master title style
         SPONSORS       buying results and
          BUYING?         value, not time,
                                                              work,
                                     Click to edit Master title style   or effort.




RIGHT-SIZEDTM CLINICAL RESEARCH SERVICES                                      www.clinipace.com
Why value-based price?
       Clients know from the outset what the study will
       cost and can budget appropriately for it.
       Clients find the predictability especially valuable
        Click to edit Master title style
       in a turbulent economy, when cost containment
       and cash flow management is crucial.
       Clients appreciate not getting hit with costs
       associated with scope Master title style should have
                      Click to edit changes that
       been anticipated from the beginning.




RIGHT-SIZEDTM CLINICAL RESEARCH SERVICES           www.clinipace.com
Common resistances to value-
          based pricing
Sponsor                                    CRO
       Different definitions of value           Little control over
         Perception of risk                        outcomes

          Click to edit Master title style
         CRO has little control over            Sponsors reluctant to
          clinical results                          share metrics
         Inertia                                Requires much greater
         Timing of measures                        pre-project feasibility
                          Click to edit Master  Inertia
          Can discourage collaboration          title style
          around performance metrics             Requires accounting
         Shared risk affects price                 innovation
         Purchasing groups dis-                 Works best for new clients
          incentivized                              and projects


RIGHT-SIZEDTM CLINICAL RESEARCH SERVICES                          www.clinipace.com
A better model
       Sponsor/CRO first defines scope of value and
       performance metrics
       Sponsor/CRO then determines scope of work
        Click to edit Master title style
       Agreement of team composition and tenure
       CRO utilizes value-led costing rather than cost-
       led pricing
       Sponsor/CRO agreeedit Master title style methods –
                     Click to upon invoicing
       based on predictability not hours worked
       Measurement systems provide continuous
       assessment of value creation

RIGHT-SIZEDTM CLINICAL RESEARCH SERVICES            www.clinipace.com
Activity-led billing

       Service  Cost  Billing  Value  Sponsor

        Click to edit Master title style
        Sponsor  Value  Price  Cost  Service
                                     Click to edit Master title style



                               Value-led pricing
RIGHT-SIZEDTM CLINICAL RESEARCH SERVICES                                www.clinipace.com
The Value-Oriented CRO
                                            Strategy
                                            Delivery
        Click to edit Master title style
                                           Technology
                                     Click to edit Master title style
                                             Metrics
                                               Value
RIGHT-SIZEDTM CLINICAL RESEARCH SERVICES                                www.clinipace.com
Foundations of value pricing
       Focuses on value and effectiveness, not time and
       labor
       Places more importance on results instead of
        Click to edit Master title style
       effort
       Fosters creativity and innovation instead of a
       unit-volume production mentality
       Incentivizes CRO toedit Master title style
                      Click to reduce time and costs
       Shares risk between sponsor and CRO
       Aligns the interests of the sponsor and CRO


RIGHT-SIZEDTM CLINICAL RESEARCH SERVICES        www.clinipace.com
The CRO of the Past
                                                                        Activity-Based
          Profit                      Capacity           Efficiency
                                                                             Price

        Click to edit Master title style
                                    Intellectual                         Value-Based
          Value                                        Effectiveness
                                      Capital edit Master title style
                                     Click to                                Price




                       The CRO of the future
RIGHT-SIZEDTM CLINICAL RESEARCH SERVICES                                      www.clinipace.com
In summary…
                                                  Variable                                   Fixed
                              Hourly             Functional               Unit-
                                                                                        Value-Based
                              Billing           Outsourcing               Based

                                                Functionally-     Input-              Output-
Contract Focus            Task-oriented
                                                 oriented           oriented             oriented

          Click to edit Master title style
Billing Unit
                          Actual Hours
                            in arrears
                                                FTE-based
                                                                   Actual Units
                                                                    Milestones
                                                                                   /
                                                                                        Planned     Units

                          Highly               Slightly          Highly              Fixed /
Monthly charges
                            variable             variable           variable             smoothed
                                       Click to edit Master title style
                          Estimated            Resources x       Estimated
Upper limit driver                                                                      Fixed Price
                            Hours                Duration           Units or Fixed
                                                                   “Cookie-            Complex,
                                                Balance sheet
Best for….                Consulting                               cutter”              shared risk
                                                 mgmt
                                                                    projects             projects

  RIGHT-SIZEDTM CLINICAL RESEARCH SERVICES                                             www.clinipace.com
Q&A

                                     Mark Shapiro
                                 mshapiro@clinipace.com
        Click to edit Master title style
                                        David Hinds
                                   dhinds@clinipace.com
                                     Click to edit Master title style




RIGHT-SIZEDTM CLINICAL RESEARCH SERVICES                                www.clinipace.com

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Clinipace worldwide-webcast-new-cro-pricing-model-value-based-vs-hourly

  • 1. Variable Billing vs. Fixed-Price Models: How Does Your Clinical Trial Stand to Gain? Click to edit Master title style Mark Shapiro, MA, MBA, CCRA, RAC Executive Director, Clinical Solutions Click to edit Master title style CLINIPACE WORLDWIDE David Hinds, MBA Global Project Director CLINIPACE WORLDWIDE
  • 2. Technology-Amplified CRO Frictionless Services Project Management Site Selection and Global Study Feasibility Click to edit Master title style Clinical Monitoring and Site Management Data Management Biostatistics Medical Management/Monitoring Patient Recruitment to edit Master title style Click Regulatory Services  GxP Quality Assurance Medical Writing Drug/Device Safety RIGHT-SIZEDTM CLINICAL RESEARCH SERVICES www.clinipace.com
  • 3. Let’s get on the same page Variable Billing Fixed-Price Click to edit Master title style Hourly Functional Unit- Value-Based Billing Outsourcing Based Click to edit Master title style RIGHT-SIZEDTM CLINICAL RESEARCH SERVICES www.clinipace.com
  • 4. So, here we are… CROs get paid for hours worked or tasks performed, not value provided CROs earn most of their money from high- volume task-level activities {the area least valued Click to edit Master title style by sponsors} CRO pricing is often based on costs or effort not value CROs have extensive, Master title style Click to edit process-based intellectual property for how to conduct of the trial, but… Have commoditized their services and removed value from services in favor of units and volume RIGHT-SIZEDTM CLINICAL RESEARCH SERVICES www.clinipace.com
  • 5. Variable billing is killing drug development, because it Misaligns interests of the CRO and client… By not sharing project risk with the client Click to edit Master title style By focusing on costs, not value creation Focuses on efforts and inputs, not results, which… Promotes a Click to edit Master title style a commodity view of services as Penalizes technological innovation Does not differentiate RIGHT-SIZEDTM CLINICAL RESEARCH SERVICES www.clinipace.com
  • 6. THE CRO Hourly, effort- Click to edit Master task-based STATUS and title style QUO: to edit Masterpricing leads to Click title style scope changes and change fees RIGHT-SIZEDTM CLINICAL RESEARCH SERVICES www.clinipace.com
  • 7. 6 reasons we should change the status quo 1. It is time consuming without adding value 2. It makes clients nervous 3. It encourages lower productivity 4. Click to edit Master title style It lends itself to tedious work 5. It doesn't stop scope creep 6. It encourages an adversarial relationship Click to edit Master title style RIGHT-SIZEDTM CLINICAL RESEARCH SERVICES www.clinipace.com
  • 8. Drivers that are pushing traditional ways of billing aside the recognition that hourly billing is excessive in difficult economic times a gnawing feeling that clients are poorly served Click to edit Master title style by hourly billing and the bidding practices that it engenders a shift toward building strategic relationships between CROsClick to edit Master title style and sponsors the desire to mitigate risk and contain budgets. http://www.lifescienceleader.com/index.php?option=com_jambozine&layout=article&view=page&aid=3931 RIGHT-SIZEDTM CLINICAL RESEARCH SERVICES www.clinipace.com
  • 9. WHAT ARE Sponsors are Click to edit Master title style SPONSORS buying results and BUYING? value, not time, work, Click to edit Master title style or effort. RIGHT-SIZEDTM CLINICAL RESEARCH SERVICES www.clinipace.com
  • 10. Why value-based price? Clients know from the outset what the study will cost and can budget appropriately for it. Clients find the predictability especially valuable Click to edit Master title style in a turbulent economy, when cost containment and cash flow management is crucial. Clients appreciate not getting hit with costs associated with scope Master title style should have Click to edit changes that been anticipated from the beginning. RIGHT-SIZEDTM CLINICAL RESEARCH SERVICES www.clinipace.com
  • 11. Common resistances to value- based pricing Sponsor CRO  Different definitions of value  Little control over  Perception of risk outcomes Click to edit Master title style  CRO has little control over  Sponsors reluctant to clinical results share metrics  Inertia  Requires much greater  Timing of measures pre-project feasibility  Click to edit Master  Inertia Can discourage collaboration title style around performance metrics  Requires accounting  Shared risk affects price innovation  Purchasing groups dis-  Works best for new clients incentivized and projects RIGHT-SIZEDTM CLINICAL RESEARCH SERVICES www.clinipace.com
  • 12. A better model Sponsor/CRO first defines scope of value and performance metrics Sponsor/CRO then determines scope of work Click to edit Master title style Agreement of team composition and tenure CRO utilizes value-led costing rather than cost- led pricing Sponsor/CRO agreeedit Master title style methods – Click to upon invoicing based on predictability not hours worked Measurement systems provide continuous assessment of value creation RIGHT-SIZEDTM CLINICAL RESEARCH SERVICES www.clinipace.com
  • 13. Activity-led billing Service  Cost  Billing  Value  Sponsor Click to edit Master title style Sponsor  Value  Price  Cost  Service Click to edit Master title style Value-led pricing RIGHT-SIZEDTM CLINICAL RESEARCH SERVICES www.clinipace.com
  • 14. The Value-Oriented CRO Strategy Delivery Click to edit Master title style Technology Click to edit Master title style Metrics Value RIGHT-SIZEDTM CLINICAL RESEARCH SERVICES www.clinipace.com
  • 15. Foundations of value pricing Focuses on value and effectiveness, not time and labor Places more importance on results instead of Click to edit Master title style effort Fosters creativity and innovation instead of a unit-volume production mentality Incentivizes CRO toedit Master title style Click to reduce time and costs Shares risk between sponsor and CRO Aligns the interests of the sponsor and CRO RIGHT-SIZEDTM CLINICAL RESEARCH SERVICES www.clinipace.com
  • 16. The CRO of the Past Activity-Based Profit Capacity Efficiency Price Click to edit Master title style Intellectual Value-Based Value Effectiveness Capital edit Master title style Click to Price The CRO of the future RIGHT-SIZEDTM CLINICAL RESEARCH SERVICES www.clinipace.com
  • 17. In summary… Variable Fixed Hourly Functional Unit- Value-Based Billing Outsourcing Based  Functionally-  Input-  Output- Contract Focus  Task-oriented oriented oriented oriented Click to edit Master title style Billing Unit  Actual Hours in arrears  FTE-based  Actual Units Milestones /  Planned Units  Highly  Slightly  Highly  Fixed / Monthly charges variable variable variable smoothed Click to edit Master title style  Estimated  Resources x  Estimated Upper limit driver  Fixed Price Hours Duration Units or Fixed  “Cookie-  Complex,  Balance sheet Best for….  Consulting cutter” shared risk mgmt projects projects RIGHT-SIZEDTM CLINICAL RESEARCH SERVICES www.clinipace.com
  • 18. Q&A Mark Shapiro mshapiro@clinipace.com Click to edit Master title style David Hinds dhinds@clinipace.com Click to edit Master title style RIGHT-SIZEDTM CLINICAL RESEARCH SERVICES www.clinipace.com