Accurate Budgeting of a Phase 2/3 Oncology Study

3

Hours of Effort

to create the study budget and scenarios in Clinical Maestro

4

Scenarios Built

Ranged from $34.9M to $43.1M depending on complexity and service assumptions

-1.9%

Variance

between Awarded CRO budget and Clinical Maestro™ calculated budget in Original scenario.

-12%

Variance

between Awarded CRO budget and Clinical Maestro calculated budge

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The Sponsor provided key assumptions from a recently outsourced study in an excel file. No protocol or study design was provided. The study was modeled as high complexity using Clinical Maestro's PORTFOLIO application for planning and budgeting. A preferred discount rate of 10% was applied.

Study description

  • Phase 2/3
  • Therapy Area: Oncology
  • Indication: Relapsed and/or Refractory Multiple Myeloma (RRMM)
  • 19 Countries (NA, EU, APAC, Japan)
  • 113 Sites
  • 600 Patients Screened
  • 300 Patients Enrolled
  • 240 Patients Completed

Results

With limited context provided by the Sponsor (no protocol, bid grid, tasks or responsibilities), the study budget built using Clinical Maestro was calculated to be $43,043,261 in direct fees. This presents a -12% variance from the awarded budget (Top Tier CRO).

Conclusions

Clinical Maestro is a reliable tool for modelling large, high complexity studies.

Study scenarios built in Clinical Maestro can be effectively leveraged during budgeting, long- range planning, and CRO bid negotiations to optimize direct costs, plan possible operations scenarios, and increase efficiency of the overall outsourcing process.

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