Artha integrates with your EDC, runs automated compliance checks, and generates complete monitoring visit reports with AI-written narratives. Your CRAs review and approve — not write from scratch.
FDA E6(R3) aligned · 21 CFR Part 11 ready · SOC 2 compliant
After every site visit, Clinical Research Associates spend hours writing 10-15 page reports. Reports are chronically late, delaying safety escalations and regulatory filings.
Artha connects to your existing clinical infrastructure. No workflow disruption.
Artha integrates with Medidata Rave, Veeva Vault, Oracle Clinical, and other major EDC systems. Securely pulls visit data, query status, protocol deviation logs, and regulatory binder records.
One-time setupFor each monitoring visit, Artha runs source data verification, protocol deviation detection, consent version tracking, eligibility checks, and SAE reporting verification — automatically.
~10 minutes computeArtha generates a complete monitoring visit report with AI-written narratives. Your CRA reviews findings, adds site-specific context, approves, and submits. Done.
~30 minutes QAArtha runs comprehensive compliance verification that would take a CRA hours to complete manually.
Cross-references CRF entries against source documents. Flags discrepancies in real-time with page-level citations.
Scans visit data against protocol parameters. Categorizes deviations by severity and tracks resolution status.
Verifies essential document completeness per ICH E6. Identifies missing or outdated documents before they become findings.
Confirms subjects signed the current IRB/EC-approved consent. Flags version mismatches and re-consent requirements.
Validates inclusion/exclusion criteria adherence. Identifies enrollment deviations before they impact data integrity.
Cross-checks adverse event timelines against regulatory reporting windows. Ensures no safety signals are missed or late.
Based on industry averages for a mid-size CRO managing 15 active studies.
Artha connects to the EDC systems you already use. No data migration, no workflow changes.
New regulatory guidance explicitly encourages technology-enabled monitoring. Artha aligns with this trajectory.
The updated ICH E6(R3) guideline emphasizes risk-based quality management and technology-enabled processes. Artha's automated compliance checks are designed to align with the proportionate monitoring approach mandated by R3.
WHO's 2025 guidance on clinical trial oversight encourages sponsors to adopt centralized monitoring tools and automated data verification. Artha implements these recommendations at the report generation layer.
30-minute live demo with your own study data. No slides, no fluff — just the report.
We'll reach out within 24 hours · No commitment required