Vita Data Sciences Case Study: Integrated Summary of Safety (ISS) Analysis Using Pooled SDTM Datasets
The sponsor is a multinational biopharmacautical company focusing in the treatment of rare diseases. Vita Data Sciences was contracted to pool data from eight studies for ISS analysis.
The main challenge that the sponsor was facing was that many of the studies were in different phases. This included one study that was a single/multiple ascending dose phase 1 study, and two other studies that were legacy and managed by a different vendor with different SDTM mapping approaches.
VDS developed pooled SDTM datasets from the study-level SDTM datasets in order to generate the integrated ADaM datasets. These ADaM datasets were then used as a source to create the Tables, Listings and Figures. As Vita Data Sciences was the primary vendor for 6 of the 8 studies, and these were deemed “submission-ready.”
After Vita Data Sciences was complete with this project, the sponsor was able to file the regulatory submission, as planned. Vita Data Sciences continues to work with the sponsor on regulatory response, as well as providing statistical programming on other clinical trials.