Comment from NexTrial AI LLC
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Summary: NexTrial.ai, an operating company developing AI infrastructure for clinical trial activation, supports the proposed pilot program and proposes a specific "proof certificate" architecture as a shared infrastructure standard. They argue that trustworthy AI in regulated environments requires a deterministic verification layer that produces verifiable, reproducible artifacts rather than relying on probabilistic confidence scores.
NexTrial.ai submits the attached public comment in response to Docket FDA-2026-N-4390. The comment proposes that trustworthy AI in regulated clinical decisions depends on a verification layer held architecturally separate from the model that produces the decision: a determination is proven correct against the applicable rule, not scored for confidence. The architecture is a risk pre-gate, three uncorrelated verification gates, and a signed proof certificate designed to re-earn against system state as the system learns. The comment responds to the Agency's questions on trustworthiness, AI system performance, participant safety and data integrity, comparative evaluation, operational structure, and knowledge sharing, and it proposes a public, architecture-neutral certificate schema and validation harness, owned by no participant, as candidate shared infrastructure for the pilot. The full comment, including figures, is attached as a PDF. Submitted under an engagement, not endorsement, posture.