The Challenge
A mid-sized CRO conducting Phase II and III studies across multiple continents was storing over 1TB of fragmented trial data on AWS S3. Their datasets — spanning eCRFs, lab reports, imaging metadata, and safety logs — were siloed, inconsistently labeled, and difficult to analyze. Regulatory teams were struggling to trace audit trails, and the data management group lacked visibility into anomalies or missing entries.
The company faced:
- Delays in clinical data reconciliation and interim analysis
- Difficulty mapping data to CDISC SDTM formats
- Uncontrolled cloud costs due to bloated storage and redundant pipelines
- Lack of audit-readiness with missing or non-standard metadata
Our Solution
Agile Genix deployed a specialized data engineering and compliance team to design a secure, scalable, and inspection-ready solution on AWS.
✅ Data Pipeline & Normalization
We built custom ETL pipelines using AWS Glue and Step Functions to clean, normalize, and tag datasets across regions — making them CDISC-ready.
✅ Automated Metadata Enrichment
Leveraged machine learning to auto-classify trial data and enrich with audit-relevant metadata (e.g., timestamps, authorship, protocol linkage).
✅ CDISC Mapping + SDTM Layering
Integrated transformation logic to convert raw trial data into SDTM format, aligned with FDA submission standards.
✅ Cost Optimization & Compliance Controls
Used AWS S3 lifecycle policies, versioning, and encryption at rest/in transit to minimize spend and align with 21 CFR Part 11 and GxP expectations.
✅ Real-Time Data Insights
Enabled dashboards for clinical ops, medical monitors, and QA to view anomalies, trends, and submission progress — powered by Amazon QuickSight.
Impact Delivered
- 60% reduction in time required for interim analysis reporting
- 100% traceability of data changes through version-controlled S3 and audit logs
- 30% lower AWS spend via tiering and deduplication
- Inspection readiness for FDA and EMA regulatory audits
Let’s Solve Your Clinical Data Bottlenecks
If your CRO or clinical ops team is struggling to manage growing volumes of unstructured or non-compliant trial data — we can help.
Book a Consultation
Talk to a specialist about how Agile Genix can help you organize, standardize, and secure your clinical data infrastructure.