Recruitment-Creative Regulatory Operations

The problem

This is a pain that did not exist twelve months ago. The September 2025 FDA enforcement wave lengthened compliance review of recruitment advertising.

ICH E6(R3) added continuous vendor-oversight documentation, so the paperwork burden persists across the life of the study rather than clearing at start-up.

Recruitment budgets are rising on legal overhead rather than media — the spend is going to review cycles, not to reaching people.

What you get

Review of recruitment creative against 21 C.F.R. § 312.7 and IRB expectations before it reaches a review board, so materials clear on the first pass more often.

The vendor-oversight documentation ICH E6(R3) expects, produced as a by-product of the review rather than reconstructed later.

A short sales cycle with a clinical-operations budget owner, no MLR dependency, and no kickback exposure — it shares a team with the lay-summary line.

How it is priced, and why

Per study or as a monthly retainer, set in advance. Nothing in this line varies with the number of people recruited.

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.

Promotional claims about investigational drugs are restricted, and recruitment advertising is IRB-reviewable material.

21 C.F.R. § 312.7

Continuous vendor-oversight documentation is expected.

ICH E6(R3)