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QARP AI Audit Assistant — Founding Users
🔬 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.

Get Lifetime Access — $297 See Prototype ↓
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 — never leaving you alone in the process.

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 is the system that coordinates agents, parses documents, and builds the report.

System Architecture
🧠

QARP AI — The Brain

Gemini 2.5 Pro + RAG Layer
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) Vertex AI RAG 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 v3 5 subjects enrolled after amendment effective date without updated ICF. Ref: ICH E6(R3) §4.8.2, 21 CFR 50.25.
Major
Investigational Product — Temperature excursion not documented IP storage log shows gap Apr 3–5. No deviation report filed. Ref: ICH E6(R3) §5.13.
Minor
Training Records — 2 staff members with expired GCP certificates CRC 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 notifications.
CAPA: (1) Obtain re-consent from affected subjects within 5 business days; (2) Update SOP-IC-03 to include amendment trigger checklist; (3) Retrain all site staff within 14 days.

Founding Users Deal

Get in before launch. Pay once, use forever.

Only 20 founding user spots. Early access starts May 12, 2026.

🔐 Founding User — Lifetime Access
$297one-time payment
Regular price: $97/month — save over $1,000/year
  • ♾️Lifetime access — pay once, use forever. All future updates included.
  • 🧪Early tester access — May 12 launch, before public release. Shape the product.
  • 🧠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
💳 Pay by Card (Stripe) 🏦 Bank Transfer (SEPA/SWIFT)
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 — your access will be 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 (outside EEA)CHASDEFX
BankRevolut Bank UAB, Branch in Spain
Bank AddressCalle Príncipe de Vergara 132, 4ª planta, 28002 Madrid, Spain
AmountEUR 297 (or USD 297 equivalent)
Payment 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
Available
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Your spot
Available

FAQ

Questions & Answers

What is "lifetime access" exactly? ▾
You pay $297 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 the 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? ▾
As a founding user you are actively shaping the product. If after your first 30 days of testing you are not satisfied, contact us at maxim.bunimovich@theqarp.com and we will issue 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 297 to THE QARP ACADEMY S.L., IBAN ES66 1583 0001 1793 4976 6470, BIC REVOESM2. Use "FOUNDING-USER-[YOUR NAME]" as reference. Send confirmation to maxim.bunimovich@theqarp.com.
What is THE QARP ACADEMY SL? ▾
THE QARP ACADEMY S.L. is a Spanish limited company (registration B19913078), headquartered in Castelldefels, Spain. Director: Maxim Bunimovich. The company 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 — $297

Questions? maxim.bunimovich@theqarp.com