The PROOF™ Method
A five-stage, principal-led process for choosing your CRO, from first requirements to a contract-ready award by the end of Week 12, then through the negotiation and the first 90 days following signature. Each stage ends in a deliverable you review and sign off before the next begins.
Already partway through? PROOF can begin at any stage.
The Steps Explained
Position the Program
Define what “right” looks like for your program before any CRO sees the study.
Without that decision, the first polished capabilities presentation you see will make it for you.
- Timing
- Weeks 1–2
- Your time
- About 4 hours
- You sign off
- Selection criteria, before any bid arrives
Right-size the Field
Invite only the CROs that can genuinely win on fit, not on reputation alone.
A short list of strong contenders draws better proposals and more senior attention than a long list assembled to feel thorough.
- Timing
- Weeks 2–3
- Your time
- About 2 hours
- You sign off
- A shortlist with a clear reason for every cut
Orchestrate the Bid
Make every proposal comparable and test every promise with the team that would run your study.
Every proposal rests on its own assumptions, so the totals mislead until those assumptions are made visible and consistent.
- Timing
- Weeks 4–7
- Your time
- About 8–10 hours, mostly bid defenses
- You sign off
- Bids you can compare line by line
Optimize the Award
Close every gap between the winning proposal, the budget, and your needs, so you are ready to go to contract.
Terms agreed now have to keep working when the study changes, and every study changes.
- Timing
- Weeks 8–12
- Your time
- About 4 hours
- You sign off
- A board-ready award, ready to go to contract
Negotiation through signature continues in Fortify the Start.
Read: A CRO Contract That Holds When the Plan ChangesFortify the Start
Stay through negotiation and the first 90 days after signature, so the CRO delivers what it sold.
Agreed terms can slip in negotiation, and delivery can drift in the weeks after signature, while teams assemble and sites are approached.
- Timing
- Contract-readiness through day 90 after signature
- Your time
- About 1 hour per checkpoint, plus your legal counsel during negotiation
- You sign off
- A signed contract that matches the agreed terms, governance in place, and a 90-day health check
Includes up to two rounds of contract negotiation; additional rounds are scoped separately.
Read: Why the First 90 Days Decide What Your CRO DeliversThe Outcome Ledger
Proof, in numbers.
Every PROOF Complete engagement ends with a one-page Outcome Ledger, issued at contract-readiness, that shows what the selection delivered. With Fortify, the Ledger closes at day 90 after signature.
Every line traces back to a proof point you signed.
Issued at contract-readiness
PROOF Complete- Time to contract-readinessSchedule maintained
- Field right-sizedFit over reputation
- Normalization gapReal price difference exposed
- Actual vs. your approved budgetBudget grounded in your study
- Key personnel committedTeam continuity
- Assumptions closedChange-order risk removed
- Award traced to signed criteriaA decision your board will understand
Closing entries at day 90
With Fortify- Terms heldAgreed terms carried into the signed contract
- Named team in placeThe team you chose is running your study
- Startup against planThe CRO delivers what it sold