Budgeting and Sourcing of a Phase 3 Rare Disease Study

CLIENT:

A mid-sized Bay-area biotech came to Strategikon for assistance with their RFP process of a Phase 3 clinical trial for neurodegenerative rare disease.

STUDY DESCRIPTION:

• Phase 3 study
• 80 sites
• 600 patients
• 21 countries
• Training and support was provided to both Sponsor and CRO teams throughout the exercise.

PLAN and BUDGET

A pre-RFP clinical trial budget was built in Clinical Maestro PORTFOLIO using our proprietary INTELLIGENCE BANK. Baseline budget was leveraged to negotiate bids during outsourcing process.

INITIATE RFP

Client created an electronic RFP from in SOURCE Application. Bidders (CROs) were set-up in the VISION application for bid and contract management.

BID to CONTRACT

Using SOURCE, four CROS were invited to bid directly in Clinical Maestro. The bid due diligence, provider scoring and contract award were conducted in Clinical Maestro™.

Results: Accuracy

Three of four CROs invited responded to the RFP in Clinical Maestro. The fourth CRO submitted using traditional methods and served as a control group. The Study Budget created in PORTFOLIO was within 98% of the median of the submitted budget proposed by the four CROS.

Results: Efficiency

The sourcing of the Study was completed in 101 fewer hours, or 84% faster using the Clinical Maestro SOURCE module over traditional sourcing tools (Word, Excel, e-mail).