Not a tool powered by AI. The AI itself — purpose-built on the rules, frameworks, and cross-document logic that govern human subjects research. Every regulation checked. Every gap found. In minutes.
Sponsors get speed. Boards keep judgment. Everyone gets citations.
“Residual saliva stored at −80°C for up to 10 years for future biomarker research.”
“Samples destroyed no later than 6 months after final assay. Banking: No.”
“Your saliva samples will be destroyed after the cortisol analysis is complete.”
Three documents describe the same biospecimens three different ways. The consent form also omits all three 2018 Common Rule biospecimen elements. Reconciliation required before board review.
Illustration of an actual Sunethix finding, from a masked demo submission. No real PHI, study, or investigator.
Dozens of focused operations per submission. The model does the work — the system runs the loop, records every step, and keeps the audit trail.
Reads every document — protocol, consent, HIPAA, recruitment — and extracts structure, key facts, and cross-document relationships.
Runs 250+ rules in three tiers: federal baseline, your institution's rules, and site-level overrides. Each rule fires independently — repeatable, defensible.
Assembles a shareable, audit-ready report. Every PASS, WARN, and FAIL traced to its citation, page, and section.
End to end: 20–25 minutes per full review. Every finding cites the exact regulation — like 45 CFR 46.116 — the document location, and a plain-English rationale.
Each submission type triggers its own rule set — different CFR sections, different required elements, different cross-document checks. Nine specialized engines, one review.
Every node is a versioned, auditable rule. Every connection is a cross-document check. This is what reviews your submission — drag it.
Sunethix runs dozens of focused operations per submission. The model does the work — the system runs the loops. Here's why that matters.
A 200-page submission, 30 instructions, and 250 rules in one shot: the obvious gets caught, the subtle gets missed. This is documented model behavior.
Run the same prompt twice on the same submission and get two different lists. No audit defense. Decomposition is what makes output deterministic.
The model knows what it said — not what it did. The orchestration layer records every step. That record is the audit packet.
The line we hold between review and substitution.
Never fabricates clinically sourced content from training data. If it isn't in the submitted documents, it isn't in the finding.
Flags regulatory discrepancies and missing elements. The ethical and scientific judgment stays with your board.
Every claim points back to the document it came from. Verification is fast by design.
Every review logs the rule version, document location, and rationale. Auditors see exactly what was checked, and when.
Sunethix is a first pass, not a final word. Approval authority, ethical judgment, and the board's mandate under 45 CFR 46 stay exactly where the regulations put them — with your HRPP.
A tireless first pass that never replaces the board. Every submission triaged in minutes — your experts spend their time where human judgment is irreplaceable.
Give investigators across every department the same pre-review the board runs — protocols and consent forms checked against your institution's rules before they reach the HRPP.
Every day a package sits in revision is a day of enrollment lost. Pre-screen against the same rules the IRB runs — and walk into the board meeting clean.
Sunethix works at every point in the chain — sponsors, CROs, universities, academic medical centers, health systems, research sites, and IRBs. When everyone reviews against the same rules, everything that reaches the board is already better.
Contact us and a Sunethix representative will walk you through the platform, configure it around your program, and put together pricing that fits — whether you're a sponsor, university, health system, CRO, or IRB.
One conversation covers everything — a live review on your own submission, the configuration, and the quote.
Talk to a representativeBring a real protocol and watch findings appear live, cited to the regulation and the page — twenty-five minutes, start to finish. The same conversation covers pricing for your program. Sponsors and CROs: bring your slowest study. IRB teams: bring your busiest week.
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A Sunethix representative will reach out within one business day.