Converting Legacy Data to CDISC Standards for Regulatory Submission
- Client: A Global Pharmaceutical Company
- Year: 2024
- Impact: Enabled the company to leverage historical data, strengthening their submission and securing regulatory acceptance.
A global pharmaceutical company needed to convert legacy clinical trial data into CDISC standards to support the submission of a new study. The challenge was to transform older datasets into SDTM IG 3.3, ensuring consistency and compliance with current regulatory expectations.
Challenges We Faced
Lack of Standardized Raw Data Formats: The legacy data had no consistent naming conventions or formats, making it impossible to apply an automated framework. Every dataset required manual review, mapping, and transformation to align with SDTM IG 3.3.
Complex Protocol Deviation Handling: The DV (Deviations) domain required special attention as protocol deviations were poorly captured in the original data. We had to develop custom logic to ensure accurate representation in the SDTM dataset.
Tight Timelines: With submission deadlines fast approaching, the project required efficient coordination and rapid execution to ensure timely delivery without compromising data quality.
Our Approach & Impact
Meticulous data mapping and transformation to align non-standard legacy data with CDISC requirements.
Custom solutions for protocol deviations, ensuring compliance and completeness in the DV domain.
A structured, efficient process to meet tight deadlines while maintaining submission quality.
By successfully converting and integrating the legacy data, we helped the company leverage historical trial data, strengthening their submission and ensuring regulatory acceptance. This case reinforced the importance of adaptability, technical expertise, and problem-solving in legacy data standardization.
