Confident Budgeting of a Phase 2 CNS Study

Anca Copaescu

CEO and Founder of Strategikon | Visionary in Clinical Outsourcing and Vendor Performance Management

2

Hours of Effort

to create the study budget and scenarios in Clinical Maestro

4

Scenarios Built

Ranged from $2.8M to $3.1M depending on complexity and service assumptions

+3.8%

Variance

between Awarded CRO budget and Clinical Maestro calculated budget

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The Sponsor provided key assumptions from a recently non-competitively sourced study in an excel file. No protocol or study design was provided. The study was modeled as medium complexity using Clinical Maestro's PORTFOLIO application for planning and budgeting.

Study description

  • Phase 2
  • Therapy Area: CNS
  • Indication: Treatment-Resistant Depression
  • US only
  • 12 Sites
  • 138 Patients Screened
  • 90 Patients Enrolled
  • 81 Patients Completed

Results

With limited context provided by the Sponsor (no protocol, bid grid, tasks and responsibilities), the study budget built using Clinical Maestro was calculated to be $3,115,478 in direct fees. This presents a 3.8% variance from the awarded budget (Top Tier CRO).

Conclusions

Clinical Maestro's budget simulation tool predicted the study cost range with near 100% accuracy.

The reliability of benchmarking and ease of use makes Clinical Maestro an ideal tool for efficient modelling of mid-complexity studies and strategic management of non- competitive bidding.

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