The Challenge
A CRO operating for over 15 years had accumulated terabytes of clinical trial data across legacy systems — including homegrown databases, Excel sheets, and outdated EDC platforms. As they entered new therapeutic areas and scaled to multinational trials, leadership needed to:
- Migrate and harmonize historical data across 200+ studies
- Ensure data structure alignment with CDISC standards
- Implement audit trails for regulatory readiness
- Eliminate manual processes and data silos
- Prepare for sponsor audits and future FDA submissions
The internal team lacked both the technical infrastructure and domain expertise to handle the volume, complexity, and compliance needs.
Our Solution
Agile Genix deployed a multi-phase data transformation program — combining modern data engineering with regulatory intelligence.
✅ Data Assessment & Mapping
Conducted deep audits on 15 years of study data — identifying inconsistencies, duplication, and non-conforming fields.
✅ Automated Migration Engine
Built ETL scripts with schema mapping to convert legacy datasets into CDISC SDTM/ADaM-ready formats — including audit tagging.
✅ Validation & Traceability Layer
Implemented GxP-compliant logs, version controls, and lineage tracking across all migrated assets.
✅ Unified Data Warehouse
Provisioned a secure, cloud-hosted data lake on AWS, allowing authorized access by regulatory, QA, and clinical ops teams.
✅ Training & Handover
Trained internal data teams to manage post-migration processes and maintain compliance going forward.
Impact Delivered
- Migrated 15+ years of clinical data without loss or corruption
- Brought 200+ study datasets into CDISC-aligned, query-ready format
- Passed third-party audit for GxP compliance with zero critical findings
- Reduced data retrieval time from days to under 10 minutes
- Enabled regulatory teams to prep submissions using validated, centralized data
Still Sitting on Legacy Clinical Data?
Whether you’re preparing for a digital transformation, a submission, or a sponsor inspection — we can help modernize your data infrastructure with full regulatory alignment.
Book a Migration Strategy Session
Talk to our experts about unlocking the value of your historical data.