Pharmacovigilance Automation for a Contract Research Organization
Automated PV processing for a CRO handling 12,000+ ICSRs monthly, reducing processing time from 45 minutes to 12 minutes and rework from 18% to 3.5%.
Industry
Pharma & Life Sciences
Offering
Kaara Build
The Challenge
The CRO processed ICSRs from multiple sources: clinical trial SAE reports, post-marketing spontaneous reports, literature monitoring, and regulatory authority communications. Each client had different reporting requirements, MedDRA coding preferences, and causality assessment criteria. Processing a single ICSR took an average of 45 minutes, with 18% requiring rework. Scaling meant linear headcount increases with 4-6 month training periods.
The Kaara Approach
Kaara built a Pharmacovigilance Intelligence System using Kaara.Code with a comprehensive Enterprise Memory Layer that encoded each client's specific PV requirements, coding preferences, causality frameworks, and regulatory submission workflows. The system automated ICSR triage, initial coding, narrative drafting, and completeness checking while routing complex cases to human reviewers with pre-populated assessments. New safety associates were productive within 2 weeks rather than 4-6 months because the institutional knowledge was in the system, not just in people's heads.
Measurable Impact
- ICSR Processing Time: 45 minutes to 12 minutes
- Rework Rate: 18% to 3.5%
- New Associate Ramp-up: 4-6 months to 2 weeks
- Client Onboarding: 8 weeks to 2 weeks
The Compounding Build Advantage
- Client-specific PV requirements and coding preferences retained across all ICSR processing, surviving team changes
- MedDRA coding intelligence improved with every processed case, increasing auto-coding accuracy across all clients
- Regulatory submission patterns from one geography informed compliance preparation for others
- Signal detection sensitivity improved as the memory layer accumulated cross-molecule adverse event patterns