🔬 Founding Users Program — 20 Spots Only
Your AI Audit Assistant.
From Prep to Report in Minutes.
QARP AI is a GxP-native intelligent assistant that guides clinical research auditors through every phase — powered by The QARP AI — your GxP-native intelligent assistant.
2–3h
Audit Prep Saved
<60s
Report Draft Generated
100%
Source-Grounded Answers
ICH E6(R3)
& 21 CFR 11 Ready
The Problem
Auditing is exhausting — before you even start.
Every audit cycle eats hours of manual work that AI should handle.
2–3 days
📋 Pre-Audit Prep
Reviewing protocols, IBs, ICFs, TMF documents, risk signals. Building the audit program manually from scratch every time.
6–12 hrs
🔎 On-Site Audit
Juggling interview notes, document checks, and findings across topics — no system to guide what to check next or flag conflicts.
1–2 days
📝 Report Writing
Translating raw notes into structured findings, regulatory citations, root cause analysis and CAPA. All manual, all repetitive.
How It Works
Three phases. One intelligent assistant.
QARP AI accompanies the auditor from document upload to final report.
1
📂 PREPARE
- Upload protocol, IB, ICF, previous audit reports
- AI parses and extracts critical processes & risks
- Auto-generates audit program + focus areas (ICH E8 R1)
- Risk-based checklist tailored to site type
2
🔍 CONDUCT
- Live chat with QARP AI during audit
- Add notes & findings per topic tab
- Upload documents on-site — AI tells you what to request
- AI flags deviations, maps to ICH/CFR requirements
3
📄 REPORT
- Select your report template
- Orchestrator assembles all findings + notes + docs
- Full draft: findings, root cause, CAPA, regulatory refs
- Human review + final sign-off
Architecture
Brain + Hands. Not just a chatbot.
QARP AI is the domain intelligence core. The Orchestrator coordinates specialist agents, parses documents, and assembles the final report — fully automated, fully auditable.
⚙ System Architecture — QARP AI Audit Assistant
🧠
The QARP AI
ICH E6(R3), 21 CFR 11/50/312,
EU CTR 536/2014, ISO 14155,
your SOPs & checklists
Knowledge Base · GxP Expert System
⇄ API calls
📂 Document Parser AgentUploads → structured data, risk extraction, TMF completeness check
🔍 Compliance MapperFindings → ICH / 21 CFR / ISO paragraph citations
📝 Report Writer AgentAll data → structured DOCX/PDF report via template
💊 CAPA GeneratorRoot cause (5 Why, Ishikawa) + corrective actions
1
PrepareUpload docs → AI extracts risks & audit program2
ConductNotes + findings → real-time AI guidance3
ReportOrchestrator assembles → full report in <60s LangGraph Orchestrator GAMP 5 Compliant 21 CFR Part 11 Audit Trail GDPR / EU Data Residency Human-in-the-Loop
Live Prototype
What the auditor sees — at every phase.
Click the tabs to explore all three phases. The Conduct tab has a live AI chat you can interact with.
app.qarp.ai / audit / QRP-2025-01 / Central Hospital
📂 Prepare
🔍 Conduct
📄 Report
Upload protocol, IB, ICF, previous audit reports, site risk profile
Protocol_QRP-2025-01_v4.pdf
2.1 MBInvestigator_Brochure_v7.pdf
4.3 MBICF_Amendment3_signed.pdf
0.8 MBPreviousAuditReport_2024.pdf
1.2 MB🧠 QARP AI — Risk Analysis
HIGHRe-consent required after Protocol Amendment v3 (Apr 2025). Check all subjects enrolled post-amendment.
HIGHIP temperature monitoring — 2 excursion flags in previous audit. Request full storage logs.
MEDDelegation log — verify PI signature and current staff CVs.
LOWTraining records — GCP certificates expiry dates for 4 staff members.
📋 Audit Program — Generated
09:00–10:00Opening meeting + IC review
10:00–12:00Source data verification (5 subjects)
13:00–14:30IP accountability + storage
14:30–16:00TMF review + staff interviews
16:00–17:00Closing meeting
CriticalFinding #F-001 · IC
Missing re-consent — Protocol Amendment v3
5 subjects enrolled after amendment effective date (12 Apr 2025) without updated ICF signature. Amendment changed primary endpoint and added new safety assessment. Re-consent not performed.
📌 ICH E6(R3) §4.8.2, §4.8.9 · 21 CFR 50.25(a) · EU CTR 536/2014 Art. 29
Auditor note: Subjects #003, #007, #011, #015, #019 affected. PI confirmed no re-consent SOP existed for amendments.
QARP AI
Based on the missing re-consent finding, I recommend also checking: randomization dates vs amendment effective date for all 5 subjects, and delegation log for PI signature after amendment. Want me to generate the CAPA draft?Yes, generate CAPA for the ICF finding
QARP AI
Root Cause: No SOP for amendment-triggered re-consent procedure.CAPA: (1) Obtain re-consent from all 5 subjects within 5 business days; (2) Create/update SOP-IC-03 for protocol amendment re-consent; (3) Retrain all site staff within 14 days; (4) Add amendment alert to EDC workflow.
Audit Report — QRP-2025-01
Site: Central Hospital · Date: 26 Apr 2026 · Auditor: M. Bunimovich, THE QARP ACADEMY S.L.
Scope: GCP compliance audit — Informed Consent, IP Accountability, Training Records, TMF
Findings Summary
F-001 [CRITICAL] — Missing re-consent after Protocol Amendment v3 5 subjects enrolled post-amendment without updated ICF. Ref: ICH E6(R3) §4.8.2, 21 CFR 50.25.
CAPA: Re-consent within 5 days; update SOP-IC-03; staff retraining within 14 days.
CAPA: Re-consent within 5 days; update SOP-IC-03; staff retraining within 14 days.
F-002 [MAJOR] — IP temperature excursion not documented IP storage log gap Apr 3–5. No deviation report filed. Ref: ICH E6(R3) §5.13.
CAPA: File retrospective deviation report; review affected IP batches; update monitoring SOP.
CAPA: File retrospective deviation report; review affected IP batches; update monitoring SOP.
F-003 [MINOR] — 2 staff with expired GCP certificates CRC and sub-investigator certificates expired. Ref: ICH E6(R3) §4.1.
CAPA: Complete GCP retraining within 30 days.
CAPA: Complete GCP retraining within 30 days.
Conclusion
The audit identified 1 Critical, 1 Major, and 1 Minor finding. Immediate CAPA required for F-001. Sponsor follow-up recommended within 30 days.
Founding Users Deal
Get in before launch. Pay once, use forever.
Only 20 spots. Early access starts May 12, 2026.
🔐 Founding User — Lifetime Access
€700one-time payment
Regular price: €97/month — save over €800/year
- ♾️Lifetime access — pay once, use forever. All future updates included.
- 🧪Early tester access — May 12 launch, before public release.
- 🧠Custom knowledge base — your SOPs, templates, checklists loaded into QARP AI.
- 📞Direct access to the founder — onboarding call + priority support.
- 📄Founding User Agreement — legally protects your data, rights, and access.
Spots taken8 / 20 remaining
By proceeding you agree to the Founding User Agreement · Questions? Email us
Bank Transfer Details
Pay by SEPA or SWIFT Transfer
After transfer, send confirmation to maxim.bunimovich@theqarp.com — access activated within 24 hours.
RecipientTHE QARP ACADEMY S.L.
Registration №B19913078
AddressCarrer Lluís I Companys, 08860 Castelldefels, Spain
IBAN (EUR)ES66 1583 0001 1793 4976 6470
BIC / SWIFTREVOESM2
Intermediary BIC (non-EEA)CHASDEFX
BankRevolut Bank UAB, Branch in Spain
Bank AddressC/ Príncipe de Vergara 132, 4ª planta, 28002 Madrid
AmountEUR 700
ReferenceFOUNDING-USER-[YOUR NAME]
Founding Testers
The first people shaping QARP AI.
M
Maxim B.
GCP Auditor · Founder
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Your spot
Available
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Your spot
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FAQ
Questions & Answers
What is "lifetime access" exactly?
You pay €700 once. You get full access to QARP AI Audit Assistant — all current features and all future updates — for as long as the platform exists. No monthly fees. This is locked in the Founding User Agreement.
When do I get access?
Early access begins May 12, 2026. After payment confirmation, you will receive an onboarding email within 24 hours with your account setup instructions and a calendar invite for your onboarding call.
Is my patient/trial data safe?
Yes. No patient-identifiable data (PII/PHI) is ever sent to external AI models. The system is designed for anonymized or de-identified audit documents. All data is stored on EU-based infrastructure. See full confidentiality terms in the Founding User Agreement.
What regulatory frameworks does QARP AI cover?
ICH E6(R3) GCP, ICH E8(R1), 21 CFR Parts 11/50/54/56/312, EU Clinical Trials Regulation 536/2014, ISO 14155:2020 (medical devices), EAEU GCP, GAMP 5. The knowledge base is continuously updated.
Can I use it on mobile during an audit?
Yes. The web application is fully mobile-responsive. On-site you can add notes, upload documents, and chat with QARP AI from your phone or tablet. A dedicated mobile app is in development (iOS/Android, Q3 2026).
What if the product doesn't meet my expectations?
If after your first 30 days of testing you are not satisfied, contact maxim.bunimovich@theqarp.com for a full refund. This is stated in the Founding User Agreement.
How do I pay by bank transfer?
See the Bank Transfer section above. Transfer EUR 700 to THE QARP ACADEMY S.L., IBAN ES66 1583 0001 1793 4976 6470, BIC REVOESM2. Reference: "FOUNDING-USER-[YOUR NAME]". Send confirmation to maxim.bunimovich@theqarp.com.
What is THE QARP ACADEMY SL?
THE QARP ACADEMY S.L. is a Spanish limited company (B19913078), headquartered in Castelldefels, Spain. Director: Maxim Bunimovich. Specialises in GxP training, clinical research quality, and AI-powered compliance tools.
Ready to audit smarter?
Join 20 auditors who will define how AI changes clinical research compliance.
Get Lifetime Access — €700Questions? maxim.bunimovich@theqarp.com