Challenge
A global pharmaceutical company faced significant operational bottlenecks across their clinical trials process. Research teams were spending thousands of hours on manual tasks:
- Literature Review: Manually screening papers against PICO criteria
- Patient Matching: Slow, error-prone matching of patients to trials
- Drug Safety Monitoring: Labour-intensive pharmacovigilance processes
- EHR Data Access: Limited ability to test with realistic patient data
- Patient Recruitment: Manual outreach and coordination
The compliance requirements made automation particularly challenging—any solution needed to meet FDA 21 CFR Part 11, HIPAA, and GxP standards.
Solution
We built an end-to-end agentic AI platform covering 5 critical workflows:
1. Literature Review Agent
Automated screening of research papers using PICO (Population, Intervention, Comparison, Outcome) criteria. The agent reads abstracts, extracts relevant information, and flags papers for human review.
2. Synthetic EHR Data Generation
Created realistic synthetic patient records for testing and validation—enabling development without exposing real patient data.
3. Intelligent Patient-Trial Matching
AI-powered matching engine that analyses patient profiles against trial eligibility criteria, dramatically reducing time-to-enrolment.
4. Agentic Patient Recruitment Assistant
Automated outreach and scheduling coordination, handling routine communications while escalating complex cases to human coordinators.
5. Pharmacovigilance with Naranjo ADR Scale
Automated adverse drug reaction assessment using the Naranjo scale, processing safety reports at 6x previous throughput.
Architecture Highlights
- LangGraph for complex multi-step agent orchestration
- Braintrust for continuous evaluation and quality monitoring
- NVIDIA NIMs for high-performance inference
- Full audit trail for regulatory compliance
Results
The platform transformed clinical trial operations:
| Metric | Before | After | Improvement |
|---|---|---|---|
| Literature screening time | Weeks | Days | 85% reduction |
| Patient matching speed | 8 days avg | 1 day avg | 8x faster |
| Pharmacovigilance reports | 50/week | 300/week | 6x throughput |
Compliance Achievement
- Passed FDA 21 CFR Part 11 compliance review
- Full HIPAA compliance maintained
- GxP documentation standards met
- Complete audit trail for all AI decisions
Technical Details
Tech Stack
- Orchestration: LangGraph for multi-agent workflows
- Evaluation: Braintrust for continuous quality monitoring
- LLMs: OpenAI GPT-4, NVIDIA NIMs for specialized tasks
- Frontend: React/Next.js dashboard for trial coordinators
- Infrastructure: HIPAA-compliant cloud deployment
Key Design Decisions
- Human-in-the-loop: Critical decisions always flagged for human review
- Explainability: Every AI recommendation includes reasoning chain
- Audit Trail: Complete logging for regulatory compliance
- Graceful Degradation: System falls back to manual workflows if AI confidence is low
Project Details
- Duration: 6 months from kickoff to production
- Team: 4 engineers (2 AI/ML, 1 full-stack, 1 DevOps)
- Status: Live in production with ongoing support
- Compliance: HIPAA, FDA 21 CFR Part 11, GxP
Interested in AI for clinical trials or life sciences? Contact us to discuss your use case.