The world’s first AI-powered Clinical Research Associate — accelerating oversight, improving quality, and ensuring compliance.
Revolutionize clinical oversight with intelligent, ethical, and compliant AI automation.
Empower sponsors, CROs, and clinical teams with AI that improves data accuracy, reduces manual workload, and ensures compliance.
CRA-IQ was founded by experts in clinical operations and artificial intelligence with a mission to eliminate repetitive monitoring tasks and accelerate clinical discovery.
Creates Monitoring Visit Reports (MVRs),SDV,summaries, automatically.
AI-Drafted MVRs (50–70% faster completion time)
Smart SDV (focus on high-risk datapoints)
Multilingual support (reduces translation delays)
Built-in Audit Trail (21 CFR Part 11 compliant)
Integrations with major clinical trial platforms
CRA-IQ transformed the way our monitors work. The automated MVR drafts are remarkably accurate — what used to take days now takes hours.
“The AI-driven SDV prioritization helps us focus on what truly matters — high-risk datapoints. It’s improved both efficiency and audit readiness across.”
“We were skeptical at first, but CRA-IQ’s compliance features and human-in-the-loop model won us over. It’s the first AI system our QA team fully approved.”
Frequently Asked Questions
CRA-IQ’s algorithms are trained on validated clinical datasets and reviewed by qualified CRAs.
Each AI-generated report maintains over 95% accuracy, with final human verification ensuring complete regulatory compliance.
No. CRA-IQ is designed as an AI co-pilot, not a replacement.
It automates repetitive monitoring tasks such as SDV summaries and MVR drafts, while CRAs retain full control and accountability over all final outputs.
Yes. CRA-IQ is built to align with:
FDA 21 CFR Part 11
ICH-GCP E6(R2/R3)
EU AI Act
GDPR & HIPAA
This ensures that all documentation is audit-ready and inspection-compliant.
Absolutely. CRA-IQ integrates with major platforms as well as EDC, CTMS, and eTMF environments through secure API connections.
CRA-IQ supports multilingual documentation — including English, Spanish, French, German, and Japanese — helping global teams manage multi-country studies without translation delays.
Our team is ready to assist you with expert support and quick answers for any challenge you are facing today.
