AI-Powered Clinical Vendor Compliance
Clinical trial vendor audits still mean nearly a week of manual review, yet teams only sample a fraction of the compliance documentation. chiwon.ai analyzes the entire vendor package against ICH E6(R3), 21 CFR Part 11, and your sponsor requirements in minutes, surfacing what spot-checks miss. Every finding ships with a structured decision trail: who approved it, why, and when, for sponsors whose AI vendors touch study data.
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The Problem
Vendor diligence still takes five or six days, and covers a slice of the package. Manual review cannot read every SOP, validation record, and amendment against GCP, Part 11, and your protocol. Sampling is a plan to miss something.
When AI vendors touch study data, the bar for evidence goes up. Sponsors need defensible diligence: traceable criteria, reproducible review, and an audit trail regulators and QA can follow, not a spreadsheet of “we looked at some folders.”
Gaps hide in the pages nobody had time to open. A missing Part 11 control narrative or an E6(R3) gap in vendor oversight shows up after the award, or worse, during inspection. Partial review optimizes for throughput, not residual risk.
ICH E6(R3), 21 CFR Part 11, and sponsor-specific controls do not compress into a checklist. They need consistent interpretation across hundreds of artifacts. Teams need speed without trading away the integrity of the decision record.
Our Approach
Entire vendor package
Artifacts are scored with the same criteria across the submission, not a cherry-picked subset that leaves blind spots.
Structured decision trails
Every finding ties to who approved it, why, and when, so QA and oversight can replay the judgment without reconstructing it from memory.
AI vendors on study data
When models or automation touch PHI or trial records, evidence and traceability have to keep pace. chiwon.ai is built for that bar.
How It Works
Upload
Sponsor uploads their regulatory and internal compliance requirements. Vendor uploads their QMS and supporting documentation.
Analyze
The engine reads the entire document package against ICH E6(R3), 21 CFR Part 11, and sponsor-defined requirements. No sampling. Every clause, every control, every gap.
Audit
Findings are returned with a structured decision trail: what was reviewed, what passed or failed, who is accountable, and why, in audit-ready format for regulatory inspectors.
Full-Package Review
Traditional audits sample 10–20% of vendor documentation. chiwon.ai reads everything, every time.
Decision Trail
Every finding is tied to a reasoning record. Not just a signature: the why behind the approval, timestamped and traceable.
Regulatory Mapped
Built against ICH E6(R3) and 21 CFR Part 11 from the ground up. Not retrofitted compliance, native to the framework.
Inspection Ready
Output is structured for regulatory auditors, not just internal teams. Built for the moment an FDA inspector asks who approved this and why.
If you sponsor trials and need vendor diligence that keeps pace with AI on study data, tell us where your review breaks down today.
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