Role: Project Lead | Duration: 8 months | Team Size: 5 developers
Project Overview:
Architected and delivered a comprehensive R Shiny platform designed for SDTM/ADaM data pooling across multiple clinical studies. The platform features metadata-driven mapping capabilities, interactive resolution dashboards, and automated data standardization workflows that significantly reduced manual data processing time by 75%.
Key Achievements:
• Implemented automated CDISC compliance validation with real-time error detection
• Designed intuitive dashboard interfaces reducing data review time from weeks to days
• Integrated with 15+ clinical data management systems via secure APIs
• Established comprehensive audit trails for regulatory compliance (FDA/EMA standards)
Technical Architecture: R Shiny (Frontend), PostgreSQL (Data Layer), Docker (Containerization), GitLab CI/CD (Deployment), AWS S3 (Storage)
Industry Impact: Deployed across 3 pharmaceutical companies, processing 500+ clinical studies with 99.7% data accuracy