Enrollment Feasibility & Recruitment-Risk Report

The problem

Sites over-forecast. It is not dishonesty; it is the structure of the question they are asked at feasibility.

The enrolment curve flattens, and by the time that is visible in the data the options are expensive.

Rescue sites cost $30,000–$50,000 each in start-up alone, before a single participant is seen.

What you get

A protocol-level read on recruitment risk: which criteria will bind hardest, where the eligible population actually sits, and which assumptions in the site forecasts are load-bearing.

Aggregate, small-cell-suppressed demand signal at k ≥ 11 — a CMS-style convention we adopt as an internal standard. We do not describe this as HIPAA de-identified, because that is not what it is.

A written risk register you can put in front of the study team before start-up rather than after.

How it is priced, and why

A fixed fee per protocol, agreed in advance. This is an operational enrolment-risk product. It is deliberately not sold as a Diversity Action Plan compliance product: FDA’s DAP guidance remains draft, and FDORA § 3602(c) leaves the requirement inoperative until 180 days after final guidance, so no sponsor must submit one today.

The basis for what we have said

Every figure and regulatory claim on this page is traceable. If you need the underlying source before a procurement conversation, ask and we will send it.

Rescue sites cost $30–50K each in start-up.

business/DILIGENCE_2026-07-25.md

The Diversity Action Plan requirement is not currently in force; the guidance is draft and § 3602(c) leaves it inoperative until 180 days after final guidance.

FDORA § 3602(c); FDA draft guidance, docket FDA-2021-D-0789

k ≥ 11 small-cell suppression is a CMS Data Use Agreement convention, not a HIPAA standard.

CMS Data Use Agreement convention, adopted as an internal standard