A small biotech firm was trying to determine the impact of how changes in the influenza viral genome impact a patient’s response to an antiviral drug. The client came to us with a request to build out a single dataset that combines subject data, virologic data, and viral genotypic and phenotypic resistance data. Each data category needed to contain a single metric, statistic or category with uniform format and units. The information needed to be organized in the specific format that would be acceptable to the FDA. The client did not have the resources and expertise to build the dataset in-house.

“Excellent job on all this! Thank you for all your hard work on all the datasets and the technical document. I was able to download and review the documents. They all look fantastic…. This data looks ready to send to the FDA for feedback. Thank you again for all your help and hard work!”

Small Biotech Client

Certara’s Programming team constructed each dataset as a SAS Transport File for a biotech partner developing a novel antiviral agent. The data was then formatted to a vertical template format currently being developed for submission of viral drug resistance data from clinical trials. The purpose of the new template was to harmonize variables with current SDTM and ADaM standards, which will aid in the FDA review of genotypic and phenotypic drug resistance data and facilitate the merging of multiple SDTM domains and ADaM derived variables. The vertical format also streamlined and simplified reporting of genotypic resistance data, reduced the number of columns in transport datasets relative to previous resistance data templates, and allowed for relatively straightforward reporting of next generation sequencing summary analysis data and supporting information.

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