Discover how Marvin EDC enabled an academic institution to transform eight years of clinical trial data into regulatory-compliant SDTM datasets, overcoming significant technical challenges to pave the way for regulatory submission and potential market approval.
This case study demonstrates how Marvin’s integrated tools, including the Tabulator for ODM to SDTM conversion, Medical Coder for standardized terminology, and automated data transformation capabilities successfully managed over 3 million observations while maintaining data privacy compliance within the EU.
Working alongside trusted partners Sanaclis, Zifo, and Cliniva, we delivered weekly SDTM dataset updates over four months, demonstrating that even complex academic studies with evolving requirements can achieve the rigorous standards demanded by regulatory authorities like the FDA and EMA.
Key Outcomes:
- Maintained operational efficiency despite constantly changing data and mapping rules
- Enabled direct database access for SDTM creation
- Achieved regulatory compliance while respecting strict EU data privacy constraints
