The Problem
In clinical trials, Overall Survival (OS) verification is a critical evaluation metric. However, traditional verification methods faced several challenges:
- Excessive workload for CRCs: Time-consuming manual phone verification
- Inefficient processes: Risk of errors in manual data entry
- Data management issues: Difficulty in real-time progress monitoring
- Patient burden: Psychological stress from frequent phone calls
- Complexity in managing large-scale clinical trials
Our Solution
We developed a comprehensive platform integrating SMS automation and data management, achieving the following results:
- Dramatic Efficiency Improvements
- 80% reduction in CRC workload
- 90% reduction in OS verification process time
- 15% reduction in overall trial costs
- Innovative Features
- Automated OS verification through SMS
- EDC input task checking and progress management
- Flexible delivery settings based on protocols
- Detailed allowance management per subject
- Real-time data visualization (color-barrier-free)
- Enhanced Data Quality and Reliability
- Unified data management system
- Significant error rate reduction
- Real-time progress monitoring
Technical Stack
- Frontend
- Framework: React, TypeScript
- UI/UX: Color barrier-free design
- Backend
- Language: golang
- Database: PostgreSQL
- Infrastructure & External Services
- AWS (Docker, Fargate, AWS CDK)
- Communication Platform (Twilio: SMS, SendGrid: Email)
- Security
- ISO27001 certified
- HIPAA compliant
Impact
This system has revolutionized the survival verification process in clinical trials, resulting in:
- Significantly improved efficiency for Clinical Research Coordinators
- Reduced burden on patients, with ethical considerations for terminal patients
- Enhanced data accuracy and reliability, improving overall trial quality
- Accelerated drug development process
The project stands as an exemplary case of digital transformation in healthcare, with ongoing collaborative research at major Japanese university hospitals.
