Verification for AI in clinical trials

Numbers that prove themselves.

Arclio answers questions from your clinical trial data. Every answer re-runs to the identical number on a record that shows any change. A reviewer can check it without taking your word.

Book a demo How it works
A regulatory analyst asks
What is the confirmed ORR at the 75 mCi dose in the CLOVER-WaM cohort?
56.4% 95% CI 39.6% to 71.8% Verified
22 of 39 evaluable subjects. Wilson score interval, alpha 0.05.
Evidence chain 12 steps0 of 12 checked
SHA-256 hash chain. Replaying.
In production at Cellectar Biosciences on a late-phase oncology radiopharmaceutical program. 21 CFR Part 11. ICH E6(R3). CDISC SDTM.

One number you cannot back up can stall a submission.

Every number in a filing has to survive one question from the reviewer.

Show me.

Verification

Three kinds of AI answer. One survives the question "show me."

Most AI tools for clinical data now say traceable, source-linked, or attributable. Those are real properties. They are also the middle rung, not the top one.

What the reviewer can do
Black box
Traceable
Verifiable, with Arclio
See where the number came from
No
Yes
Yes
Re-run the computation and get the identical result
No
No
Deterministic
Detect if the record was altered after the fact
No
No
Hash-chained
Check the record against a standard the vendor does not own
No
No
Proof of Insight
Confirm no patient data left your environment
Varies
Varies
Runs inside yours

Traceability shows where a number came from. That is a pointer.

Verification means someone who is not you can reproduce it and confirm the record is unaltered. That is proof.

What we certify, and what we do not

Arclio certifies that the analysis was carried out exactly as specified and that the record is intact. It does not certify that the analysis plan was the right one. No record can. We say this plainly because reviewers already know it.

How it works

Three steps from raw datasets to a chain you can hand over.

1

Connect your evidence

Patient-level datasets, the analysis plan, study reports, and the literature you rely on. Arclio deploys inside your environment; no patient record moves to us.

2

Ask in plain language

Ask the way you would ask a colleague. The agent writes the query and runs the statistics, sealing every step to the chain as it goes.

3

Hand over the chain

Tables and publication-grade charts arrive with their evidence chain and a readiness score against your prespecified analyses. Give the chain to QA or the reviewer. They re-run it.

In production

Cellectar Biosciences runs a live clinical-evidence platform on Arclio.

On a late-phase oncology radiopharmaceutical program: plain-language access to trial data, on-demand efficacy and safety analysis, and readiness reporting where every figure re-runs to the same result.

"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, Chief Operating Officer, Cellectar Biosciences
1 dayMinutes
Analyst turnaround on a standard efficacy question, as reported by Cellectar

Built on Proof of Insight, an open standard for verifiable records of AI analysis. Arclio is a reference implementation, not the owner. A compliance standard owned by the vendor being regulated would not hold up, so the standard is kept independent on purpose.

Pricing

Priced against the statistician line, not the software line.

Six figures and weeks per study for statistician-generated regulatory outputs. Arclio delivers comparable, CDISC-conformant outputs in a fraction of both, with a verification chain on top.

Where things stand: Arclio is production-deployed at Cellectar and in active validation against completed oncology studies. On the call we show you exactly where validation stands, without overstated claims.

Per active program, per year
Starts in the low six figures
  • Deployment inside your environment
  • Validation package for your QA team
  • The verification chain on every output
  • Readiness scoring against prespecified analyses
  • A named contact, not a ticket queue
Scope a program

Questions

What reviewers and buyers ask first.

No. Arclio runs inside your infrastructure. The agent reaches your data through structured queries you can inspect. The data itself never moves to us.
Traceability shows where a number came from. Verification means a reviewer can re-run the computation and get the identical result, and the record is hash-chained so any later change shows. One is a pointer. The other is proof.
That the analysis was performed as specified and the record is intact. Not that the analysis plan was correct. That judgment stays with your statisticians and the reviewer, where it belongs.
Patient-level datasets, statistical analysis plans, clinical study reports, and the literature you rely on, including prior trials and the public FDA record. Data handling is aligned to CDISC and SDTM expectations.
Tables and publication-grade charts, including Kaplan-Meier plots with log-rank statistics and confidence bands; literature-versus-data comparisons; and a readiness scorecard across efficacy, safety, data quality, and biomarkers. Every output ships with its verification chain.
Proof of Insight is an open, independent standard for verifiable records of AI analysis. It is not an Arclio product. Arclio is a reference implementation, and Arclio LLC serves as interim editor until an independent editorial body is in place. Keeping the standard independent is the point. Read the standard.

Bring your toughest reviewer question.

Thirty minutes on a synthetic CLR-131-style dataset. Ask anything, watch the chain seal, replay it step by step. If an answer cannot carry its own proof, you will see that too.

Book a demo Email the founder

Usually a same-week slot. No data required to start.