Case Study: a small biotech firm achieves FDA-ready virology dataset organization with Certara SAS programming

Organizing Complex Virology Datasets into FDA-Ready Format using SAS Programming

The small biotech firm needed to organize complex influenza virology data into a single, FDA-ready dataset but lacked the in-house resources and expertise to do so. They engaged Certara's Biometrics and Data Science services to handle the SAS programming required to integrate subject data with viral genotypic and phenotypic resistance information into a submission-compliant format.

Certara's programming team constructed the dataset as a SAS Transport File, utilizing a new vertical template format that harmonizes with SDTM and ADaM standards. This streamlined the data, reduced the number of columns, and simplified reporting for FDA review. The client confirmed the data was fantastic and ready to send to the FDA for feedback, successfully overcoming their submission challenge.