Upload a study protocol. Get a complete audit package — risk-based checklists, interview questions, and regulatory citations — generated by AI built for independent auditors.
Free during beta · No credit card required
Drop in a study protocol, CMP, or Investigator's Brochure. Encrypted in transit and at rest.
Risk assessment, checklists, interview questions, SDV priorities — built in minutes. Your document is processed, never stored.
Formatted Word documents with regulatory citations and risk coding. Your source file is purged automatically.
We built AuditPrep AI for people who handle the most sensitive documents in clinical research. We treat data protection with the same rigor you bring to an audit.
AuditPrep AI runs on the Anthropic commercial API, which is contractually prohibited from using customer data to train or improve AI models. Your protocols, CMPs, and study documents are never fed into any training pipeline — not now, not ever.
Contractual guaranteeAPI processing logs are automatically purged within 7 days per Anthropic's commercial data retention policy. Your uploaded documents are deleted from our servers immediately after your audit package is generated and downloaded.
Automatic purgeAll data is encrypted with AES-256 at rest and TLS 1.2+ in transit. Your protocol never travels unprotected between your browser and our processing engine. Industry-standard encryption at every step.
AES-256 + TLS 1.2+Your uploaded study documents are processed by AI only. No AuditPrep AI employee, contractor, or third party reads, reviews, or accesses your protocol content. The system is fully automated.
Zero human accessBuilt on Anthropic's commercial API tier — the same infrastructure used by regulated enterprises, healthcare organizations, and government agencies. Not a consumer chatbot. Enterprise-grade by design.
Enterprise API tierEvery processing event is logged with timestamps — when your document was uploaded, processed, and deleted. You can export this log for your own quality records or client documentation.
Timestamped logsImpact × Likelihood scoring across DOAL, IRB, ICF, PK sampling, lab procedures, IP accountability, and more. Three-tier priority coding tells you exactly where to focus.
Tailored questions for Principal Investigators, Study Coordinators, and Lab Staff — each with expected evidence and follow-up prompts based on the actual protocol.
Every checklist item anchored to specific ICH E6(R3) sections, 21 CFR references, or OECD GLP principles. No guessing. No "see guidelines."
Deep support for bioequivalence studies: PK sampling windows, deviation thresholds, PKAS criteria, fed/fasted design elements, and crossover-specific checks.
Know which records to verify 100% versus sample-based, and get a pre-built document request list to send the site before you arrive.
Every output is tagged: [Verified], [Inference], or [Gap Identified] — so you always know the certainty level behind each audit item. No black-box AI.
You don't have a team of 20. You need tools that do the prep work so you can focus on the audit itself.
Slash your prep time from days to minutes. Show up to every audit with a thorough, risk-based package — even when juggling multiple studies.
Scale your audit practice without hiring. Deliver more audits per month with consistent, high-quality preparation materials for every engagement.
Pick up new study assignments and be audit-ready in hours, not days. Impress sponsors with the depth and rigor of your preparation.
Join the waitlist for early access. Be among the first independent auditors to try AuditPrep AI when we launch.
Free during beta · Built by an auditor, for auditors