Benefit — knowing your category first
What it saves you to know before someone else asks
Every sponsor already has a Category A / B / C stance on every trial AI it runs. The question is only whether the sponsor knows it before the BIMO inspector, EMA rapporteur, DSMB chair, IRB, or diligence partner does.
The four moments
- FDA BIMO inspection or Type C meeting. Reviewer asks about AI-in-clinical-decision-support governance. If you already know you are A, the answer is a one-page hand-off. If you don't know, the follow-up probes reveal the gap in real time.
- EMA scientific-advice request. Response window is short. Knowing the category BEFORE lets the sponsor build the response around the record, not around the missing record.
- DSMB pre-read or IRB continuing-review. Board asks the AI-governance question. A/B/C answer + one-page evidence + named remediation is the credible response. "We think it's fine" is not.
- Diligence / investor review / partner licensing. AI-governance section on the diligence questionnaire. Attaching the Snapshot is the answer. Not attaching means answering narratively and hoping.
Cost of learning your category the wrong way
Reactive stance cost: external counsel + rush-audit + remediation-under-fire typically runs 5-20x the cost of the same discipline applied ahead of time. And the reactive-response record does not carry the same credibility.
Multi-stakeholder chain: once the category becomes visible via one channel (BIMO, EMA, DSMB, IRB, diligence partner), the other channels typically converge within 6-18 months. Sequential response cost stacks.
Proactive stance cost: $499. Below sponsor procurement threshold. Direct-buy. 3 business days. A/B/C determination + 3 fix-first items + signed declaration.
What "knowing" changes operationally
- Category A — keep the Snapshot on file. Cite in briefing book + DSMB pre-read + IRB continuing-review packet + diligence questionnaire.
- Category B — work the 3 fix-first items over 30-60 days. Re-audit. Move to A. Document the journey.
- Category C — freeze / hold-for-investigator-review + retention hold + notify CMO + VP Reg Affairs + Clinical Operations lead + DSMB chair. Then work the 3 fix-first items. Then re-audit. The 30-day plan is on the record you already have.
Who at your org cares
- CEO / COO — program-timeline visibility
- General Counsel — litigation-hold + response readiness
- VP Regulatory Affairs — FDA + EMA + IRB response readiness
- CFO — reserve + program-value implications
- Board Compliance + Science Committees — oversight documentation
$499. 3 business days.
Answer the question every stakeholder eventually asks — before they ask it.
Buy $499