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Clinical Trial OS Automation Platform

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  • Clinical Trial OS Automation Platform

Clinical Trial OS Automation Platform

2025/01/07

55

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.