The Challenge
A biotech sponsor was managing a large Phase III oncology trial across 12 global study sites, each using different EDC platforms, lab systems, and file formats. Data was stored in silos, manually transferred via CSVs or FTPs, and analyzed weeks after collection.
Key pain points included:
- Delayed decision-making due to data lag across regions
- No unified dashboard for trial monitoring or patient progress
- Manual consolidation errors leading to inconsistencies in protocol adherence
- Inability to generate submission-ready datasets for interim safety reporting
- Risk of non-compliance with data traceability standards
Our Solution
Agile Genix built a secure, compliant, and fully integrated data aggregation and monitoring platform to bring real-time visibility and control to the sponsor’s operations.
✅ Data Integration Framework
Developed custom APIs and ETL pipelines to pull data from 6+ EDC and lab systems into a unified staging area.
✅ Standardization Engine
Implemented automated data mapping aligned with CDISC SDTM and ADaM formats, supporting downstream regulatory submission.
✅ Real-Time Dashboards
Enabled dynamic visualizations via Power BI and AWS QuickSight — showing enrollment rates, adverse events, protocol deviations, and site-level KPIs.
✅ Global Access with Regional Compliance
Deployed on AWS with access controls by geography to align with GDPR in Europe and HIPAA in the U.S.
✅ Audit Trail & Version Control
Configured full versioning, change tracking, and user activity logs across all datasets for 21 CFR Part 11 compliance.
Impact Delivered
- Enabled real-time insights across 12 global sites
- Reduced manual reconciliation workload by 70%
- Cut safety report generation time from 2 weeks to 2 days
- Passed sponsor audit with zero findings on data handling
- Achieved standardized data model across all studies for scale
Need Help Unifying Global Clinical Data?
Whether you’re a sponsor managing global sites or a CRO overseeing data operations — we help you gain clarity, speed, and compliance with confidence.
Talk to Our Data Engineering Team
Let us show you how real-time, validated clinical data can become your competitive edge.