Twenty-eight sites multiply startup, contracts, training, monitoring and closeout before the enrollment thesis has been proven.
Illustrative worked example · $99 audit
What does the protocol audit actually find?
Here is a deliberately simplified example. The point is not the score. The point is how the audit turns a long protocol into a short list of expensive assumptions worth checking before they become contracted cost.
The illustrative protocol
Phase 1 oncology study
- 120 patients, 28 sites, 5 countries
- 12 scheduled visits per participant
- Mandatory tumor biopsy plus central imaging
- Central biomarker laboratory and sample shipping
- Blinded central review at 24 weeks
- Expected screen failure above 35%
- Several exploratory endpoints and multiple external vendors
What the audit flags
High screen failure plus biopsy and visit burden means the number of people who must be found is much larger than 120.
Five countries add startup, regulatory, contracting, vendor and sample-logistics complexity. The correct comparison is actual capable sites, not country averages.
Imaging, biomarker, IRT/eCOA and central review create handoffs that should be tested for duplication and decision value.
The more interacting procedures and vendors, the more expensive it becomes to repair an operational assumption after sites open.
Cost-to-Truth
Do not guess the dollar answer.
The audit would not invent a full trial cost from a protocol alone. It would identify the small set of actual site, vendor, enrollment and geography quotes needed to calculate a defensible Cost-to-Truth.
Cheapest credible next move: test protocol-specific feasibility and apples-to-apples cost with a small set of capable sites before activating a 28-site, five-country network.
What I would do Monday morning
- Challenge whether all 28 sites need to open before enrollment assumptions are validated.
- Map every procedure and exploratory endpoint to safety or a decision it changes.
- Obtain comparable site/geography inputs for the few locations capable of running this exact design.
Why someone pays $99
Not for a magic number. For a better question before the expensive part begins.
If the audit prevents one unnecessary site activation, one avoidable procedure, one weak geography assumption or one bad vendor scope from being locked in, the purchase price is tiny relative to the decision.
Illustrative example only. It is not a real sponsor recommendation and does not replace clinical, regulatory, statistical or safety review.