Pharmaceutical Clinical Trials Data Platform
Built secure clinical trials data management platform for pharmaceutical company conducting global multi-site studies.
- Clinical Data Management
- Regulatory Compliance
- Multi-Site Integration
- Data Analytics
36 weeks development
CLASSIFIED
Detailed specifications, architecture diagrams, and performance metrics available to qualified parties under executed NDA.
The Challenge
A pharmaceutical company needed to manage clinical trial data across 50+ global sites while maintaining GxP compliance, ensuring data integrity, supporting regulatory submissions, and enabling real-time monitoring of trial progress.
Our Approach
Developed cloud-based clinical data management system with role-based access controls, implemented electronic data capture with built-in validation rules, deployed automated audit trails meeting 21 CFR Part 11 requirements, integrated with site management systems, and built analytics dashboards for trial monitoring.
Outcomes
Managing data from 50+ clinical sites globally
100% data integrity maintained
Reduced data query resolution time by 65%
Accelerated regulatory submission preparation by 8 weeks
Technology Stack
* Specific versions, configurations, and custom integrations disclosed under NDA