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.
