The declaration verbatim
"I, Kevin Luddy, as principal of contrarianAI LLC, personally attest that:
1. contrarianAI is not an employee, contractor, equity holder, or vendor of the audited sponsor or any of its clinical-AI vendors (Deep 6 AI, TrialGPT, Antidote, Unlearn, QuantHealth, Owkin, or any similar), any CRO (IQVIA, Parexel, ICON, PPD, Syneos), or any EDC / eTMF / CTMS vendor (Veeva, Medidata, Oracle Clinical One, Castor).
2. Assessment tools (distributional-shape sensor, retrieval-auditor, tool-call-grader, prompt-drift-sensor, predictor-corrector, router-drift-sensor) use model families and evaluation methods distinct from those in production at the audited sponsor.
3. This Snapshot is based on the data-sample submitted by the buyer. Changes to the audited sponsor's infrastructure after the Snapshot date are outside this Snapshot's scope.
4. Underlying audit evidence is retained for the Snapshot horizon and will be made available for legitimate regulatory / audit / counterparty inquiry with appropriate legal process, including FDA Bioresearch Monitoring Program requests, EMA scientific-advice inquiries, ICH E6(R3) essential-documents review, DSMB safety-signal investigation, and IRB continuing-review response.
5. The independent-verifier principle applies: the control plane cannot reside within the entity it is meant to regulate. contrarianAI is that independent control plane for this Snapshot's scope."
Sample declaration — signed Kevin Luddy, Principal, contrarianAI LLC, 2026-07-22
Why "personally attest" matters
Kevin Luddy's name is on the signature. Not "contrarianAI LLC." Not "the audit team." A named principal, standing behind the statement. That is how attestations survive regulatory + legal challenge — a named person, addressable, cross-examinable.
The Big-4 pharma consultancies do this at $200K-$1M+ per engagement. The $499 Snapshot does the same discipline at 5-10% of the price by scoping tightly to one AI surface + producing one determination + retaining evidence.
What "control plane" means in a trial-AI context
A control plane is the layer that observes and governs another layer's behavior, from outside that layer. Applied here:
- The clinical-AI vendor's own monitoring is inside the vendor's plane. Vendor cannot credibly grade its own homework.
- The CRO's monitoring is inside the CRO's plane. Same principle.
- The sponsor's Clinical Operations + Regulatory Affairs teams are inside the sponsor's plane.
- An independent verifier — distinct entity, distinct methodology, distinct retention — is outside all three. That is the control plane.
"We use our clinical-AI vendor's monitoring dashboard" is the modal answer FDA BIMO inspectors reject on independence grounds. The Snapshot exists so that a defensible answer — independent verifier, signed declaration, retained evidence — can be produced at $499.