🔬 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 Gemini 2.5 Pro + your regulatory knowledge base.
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.
16 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 brain. The orchestrator coordinates agents, parses documents, and builds the report.
System Architecture
🧠
QARP AI — The Brain
ICH E6(R3), 21 CFR 11/50/312,
EU CTR 536/2014, ISO 14155,
your SOPs & checklists
⇄
📂 Document Parser AgentUploads → structured data, risk extraction
🔍 Compliance MapperFindings → ICH/CFR/ISO paragraph refs
📝 Report Writer AgentAll data → structured DOCX/PDF report
💊 CAPA GeneratorRoot cause (5 Why) + corrective actions
Gemini 2.5 Pro (1M ctx) LangGraph Orchestrator GAMP 5 Compliant 21 CFR Part 11 Audit Trail GDPR / EU Data Residency
Live Prototype
What the auditor sees on-site.
Real-time findings log + AI chat — running in the browser, mobile-ready.
QARP AI — Audit Conduct · Site: Central Hospital · Protocol: QRP-2025-01
Prepare
Conduct
Report
Findings Log
Critical
Informed Consent — Missing re-consent for protocol amendment v35 subjects enrolled after amendment effective date without updated ICF. Ref: ICH E6(R3) §4.8.2, 21 CFR 50.25.
Major
IP — Temperature excursion not documentedIP storage log shows gap Apr 3–5. No deviation report filed. Ref: ICH E6(R3) §5.13.
Minor
Training Records — 2 staff with expired GCP certificatesCRC and sub-investigator due dates passed. Ref: ICH E6(R3) §4.1.
QARP AI Chat
QARP AI
Based on the missing re-consent finding, I recommend also checking: randomization dates vs amendment effective date, and delegation log for PI signature. 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.CAPA: (1) Obtain re-consent within 5 business days; (2) Update SOP-IC-03; (3) Retrain all site staff within 14 days.
Founding Users Program
Pay once. Use forever. Shape the product.
20 individual spots + 5 corporate slots. Early access starts June 2026.
✓ Fully Booked
Early Bird · First 5 Spots
€700one-time
All 5 Early Bird spots have been reserved.
- ♾️Lifetime access — pay once, use forever
- 🧪Early tester access — June 2026
- 🧠Custom knowledge base (SOPs, checklists)
- 📞Onboarding call + founder access
- 📄Founding User Agreement
Spots taken5 / 5 — Sold out
🔐 Founding User — Individual
€900one-time
Regular price after launch: €97/month · Save €864/year
- ♾️Lifetime access — pay once, use forever. All future updates included.
- 🧪Early tester access — June 2026, before public release.
- 🧠Custom knowledge base — your SOPs, templates, checklists loaded into QARP AI.
- 📞Direct access to the founder — onboarding call + priority support.
- 🗺️Roadmap influence — your feedback directly shapes the product.
- 📄Founding User Agreement — legally protects your data, rights, and access.
Spots remaining~12 of 15
Or pay by bank transfer (SEPA/SWIFT)
🏢 3 Users · Team Access
Corporate Founding Partner
€1,500one-time
vs €2,700 if purchased individually · save €1,200 · no monthly fees ever
- 👥3 named users from your organisation, onboarded together.
- ♾️Lifetime access for all 3 — pay once, use forever.
- 🏷️Listed as Founding Corporate Partner on the product page.
- 🗺️Priority roadmap influence — your team's workflows shape features first.
- 📞Team onboarding call + dedicated ongoing support.
- 📄Corporate Founding Partner Agreement included.
Corporate slots~4 of 5 remaining
Email maxim.bunimovich@theqarp.com to discuss
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
Individual AmountEUR 900
Corporate Amount (3 users)EUR 1,500
ReferenceFOUNDING-USER-[YOUR NAME]
Founding Testers
The first people shaping QARP AI.
M
Maxim B.
GCP Auditor · Founder
+
Your spot
Available
+
Your spot
Available
+
Your spot
Available
FAQ
Questions & Answers
What happened to the €700 Early Bird price?
The first 5 Early Bird spots at €700 have been fully reserved. Current individual Founding User spots are €900 — still a one-time lifetime payment with no monthly fees ever. After public launch the regular price will be €97/month.
What is "lifetime access" exactly?
You pay once (€900 individual, or €1,500 for 3 corporate users). 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.
What is the Corporate Founding Partner package?
The corporate package gives 3 named users from the same organisation lifetime access for €1,500 one-time (vs €2,700 individually — saving €1,200). Your team is onboarded together, listed as a Founding Corporate Partner, and gets priority influence on team-specific workflow features. Email maxim.bunimovich@theqarp.com to arrange.
When do I get access?
Early access begins June 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. All documents are automatically anonymised before AI processing — personal identifiers, sponsor names, site names, and subject IDs are redacted. No patient-identifiable data is ever sent to external AI models. All data is stored on EU-based infrastructure and deleted after each session. See the Founding User Agreement for full confidentiality terms.
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 — in development for Q3 2026), EAEU GCP, GAMP 5.
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 900 (individual) or EUR 1,500 (corporate, 3 users) 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 the auditors who will define how AI changes clinical research compliance. Spots are limited.
Questions? maxim.bunimovich@theqarp.com