Rescuing a Multi-Vaccine Study Through Data Interpretation and Remapping

A global pharmaceutical company conducted a study with multiple vaccinations, but data collection issues at one visit rendered 73% of the SDTM data unusable. With most study sites already closed, traditional data queries were not an option, requiring a deep dive into existing records to salvage the dataset.

Challenges We Faced

Significant Data Gaps: Due to poor data collection at a key visit, a large portion of reactogenicity and safety data was missing or inconsistent.
Limited Site Availability: Most study sites had already closed, making direct data clarification impossible.
Lack of Proactive Data Cleaning: The data management team had not prioritized cleaning, leaving major gaps that could jeopardize submission readiness.

Our Approach & Impact

Conducted an in-depth data investigation, leveraging site responses and historical patterns to interpret missing information.
Remapped key reactogenicity domains, restructuring data to ensure maximum usability.
Increased data usability from 27% to 96%, enabling a more robust submission without compromising data integrity.

By applying strategic data interpretation and SDTM remapping, we turned a potential submission roadblock into a high-quality, regulatory-compliant dataset. This case reinforced the critical role of early data cleaning and proactive issue resolution in ensuring smooth study execution and submission success.