Proof of Insight Standard · v0.9
AI you can submit.
An agentic AI for clinical analysis where every claim is hash-chained to its evidence, every result is reproducible, and every analysis is reviewable — built for 21 CFR Part 11 from the first byte.
The agent · live
Talk to your trial. Get an answer with proof.
A regulatory analyst preparing a CLR-131 submission asks two questions. Watch what comes back — and what's recorded underneath.
The chain · verifiable
Every analysis leaves a tamper-evident trail.
Each tool call, each statistical method, each file read — recorded as a hash-chained block. Reviewers can replay the entire session, byte-for-byte, from the chain alone.
Built for two readers
A sponsor's analyst. A reviewer at the agency.
For sponsors
Submit faster, with cleaner evidence.
- ›Run readiness reviews in minutes, not weeks — the agent flags submission gaps before they reach a reviewer.
- ›Replace screenshot-and-paste evidence collection with a chain that ties every figure and table to source data.
- ›Hand the chain to internal QA, biostats, and regulatory affairs — they can replay any analysis without re-running it.
For reviewers
Trust, but verify — independently.
- ›Receive a sealed chain alongside the submission. Open the verifier, watch every block validate.
- ›Replay any statistical computation deterministically: same inputs, same code path, same hash.
- ›Inspect the reasoning behind any AI-generated finding — not as a black-box output, but as evidence-linked claims.
"
What used to take our analysts a full day now takes a couple of minutes — and we're catching patterns in clinical data we would have missed before.
Jarrod Longcor · Cellectar Biosciences
Ready to make your AI submission-ready?
See the agent run on a synthetic CLR-131-style dataset, walk through a real chain, or get the Proof of Insight Standard v0.9 in advance of publication.