- Problem
- Complex clinical-trial data needed reliable, auditable ETL under GxP, ICH-GCP, 21 CFR Part 11, and CDISC/SDTM, with full traceability for regulators.
- Approach
- Engineered end-to-end ETL pipelines and data models in SQL and Python, built data-quality monitoring frameworks, authored Data Validation Plans and SOPs, and conducted independent code reviews as a second-line control.
- Result
- Improved processing speed and reliability by ~30% and cut project turnaround by ~20% through standardised, dashboard-tracked data-quality processes.