All case studies
CasX.ai
Autonomous Pharmacovigilance Platform
CasX.ai
The challenge
Pharmacovigilance teams face growing volumes of Individual Case Safety Reports (ICSRs) and complex regulation, which leads to slow and inconsistent results.
Our solution
CasX.ai is an autonomous safety platform with dual AI agents that improve case intake, processing, quality control and regulatory submission.
Scope and delivery
Compliance is built in for E2B(R3), EMA, FDA and CDSCO requirements.
Key capabilities
- Ingests structured and unstructured data such as emails, PDFs, CIOMS, XML, literature and electronic health records
- Populates E2B(R3) fields autonomously and produces submission-ready regulatory output
- AI-driven coding (MedDRA and WHO-DD), triage, causality, narrative creation and duplicate detection
- A real-time quality control agent that checks regulatory compliance before submission
- Full audit trails, with flexible workflows and integrations for pharma, biotech, CROs and BPOs
Outcomes
- More than 50,000 case records processed
- Case processing in minutes instead of days
- 100% audit traceability
- Reported 50% to 80% reduction in pharmacovigilance cost and up to 10 times faster case processing across deployments
“I see Quantana as an organization built on resilience, trust, and strong values. Its seven-year journey reflects true grit and sustainable growth.”
Dr. Balaji Ommurugan, CasX.ai
From ambition to action
Ready to audit your enterprise AI readiness?
Discover where AI can make a meaningful difference — and what it takes to get there responsibly.