IQRA Clinical AI™ — by IQRA Clinical AI Systems

From Weeks to Minutes — Clinical Document Compliance Review, Automated

Upload your BA/BE study documents. Get a full regulatory compliance review — Rule-Based and AI-assisted — in minutes, not weeks.

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GAMP 5 Category 4 · 21 CFR Part 11 · ICH E6(R3) · NDCT Rules 2019

Compliance Review — BA/BE-2291209-Rule Engine

Rule-Based review completeAll 10 TMF phases checked, instantly

AI-assisted review runningDeeper analysis on flagged sections

2 findings need attentionProtocol §4.2 · ICD reference mismatch

Regulatory mapping completeCDSCO · USFDA · EMA · ANVISA +5

Inspection Readiness score: readyStructured findings report generated

The Problem

Manual review doesn't scale

Manual regulatory compliance review of clinical trial documents (Protocol, ICD, CRF) takes Regulatory Affairs teams days to weeks per study. A single missed requirement — a document reference, a sampling detail, a regulatory citation — can delay or derail a submission. Tracking 9+ regulatory authorities' differing requirements by hand doesn't scale.

The Solution

A 209-rule compliance engine

IQRA Clinical AI reviews your uploaded documents against a 209-rule compliance engine covering all 10 TMF phases, cross-checked against 9 regulatory authorities (CDSCO, USFDA, EMA, ANVISA, Health Canada, ICH, WHO, PMDA, TGA). Every review runs Rule-Based checks (instant, always-on) with optional AI-assisted review for deeper analysis. Get a structured findings report and an Inspection Readiness score in minutes.

What's built in

Every item below is live in the product today.

95%+ BA/BE Audit Coverage — Pilot & Pivotal Studies

9 Regulatory Authorities — CDSCO, USFDA, EMA, ANVISA, Health Canada, ICH, WHO, PMDA, TGA

Multi-tenant CRO isolation — complete data privacy

RBAC — Super Admin, Admin, Manager, Auditor, Viewer roles

Study Milestone Tracker — progressive review workflow

SAE/AE Reporting · Subject Enrolment · Inspection Readiness

2000+ page PDF support — pdfplumber + chunked OCR (50 pages/batch)

No PHI stored · 21 CFR Part 11 Audit Trail · DPDP compliant

TMF Phase Checklist — all 10 phases tracked automatically

Unlimited concurrent studies on every plan

How it works

Upload to report, in one pass.

Upload

Your Protocol, ICD, CRF, or SOP documents.

Review

Rule-Based + AI-assisted review runs automatically.

Report

Get a structured findings report + compliance score.

Export

As PDF, track fixes, re-run anytime.

Who it's for

Built for CROs and sponsors running BA/BE (bioequivalence/bioavailability) clinical trials in India and globally — from small CROs running their first pilot study to established sponsors managing multiple concurrent trials.

Current release & roadmap

Built and verified for BA/BE studies today — clinical trial phases are on the roadmap.

Current Release

BA/BE Studies

Pilot and Pivotal BA/BE studies are live today — 9 regulatory authorities, the full 209-rule compliance engine, and 21 CFR Part 11 audit trail all apply.

Roadmap

Clinical Trial Phases I–IV

Phase I through Phase IV clinical trial support is built and in pilot testing with real study data. It will open up as those pilots clear — contact us for early access.

Pricing

We're onboarding founding CRO partners — plans are tailored on a call, not fixed on this page.

PlanStatus

DemoFree

Trial7 Days

StarterContact Sales

EnterpriseComing Soon

Request a Trial Contact Sales

Built for Regulated Environments, From Day One

Multi-tenant data isolation

Your data never touches another CRO's tenant.

No PHI stored

Subject data uses initials/IDs only.

21 CFR Part 11-compliant

Tamper-evident audit trail on every review and sign-off.

Full GxP validation package available

VMP, URS, IQ/OQ/PQ, Risk Assessment — 98.3% qualification pass rate.

DPDP (India) / GDPR-aware data handling

Built around India's Digital Personal Data Protection Act, with GDPR-aware handling for global sponsors.