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R Consortium’s Submission Working Group: Advancing R for Regulatory Success at PharmaSUG 2024

By July 2, 2024Blog

The R Submission Working Group is making significant strides in promoting the use of R for regulatory submissions in the pharmaceutical industry. At PharmaSUG 2024, held from May 19-22 in Baltimore, MD, the group’s impact was evident through various insightful presentations and discussions.

One highlight was Ben Straub’s presentation, “Piloting into the Future: Publicly available R-based Submissions to the FDA,” which showcased the growing adoption of R in both industry and regulatory settings. Straub emphasized the vibrant R community and its diverse packages that enhance statistical analysis and data visualization, highlighting R’s role in facilitating efficient and transparent FDA submissions.

Additionally, André Veríssimo and Ismael Rodriguez’s presentation, “Automating SDTM Using R: A Practical Guide,” demonstrated the advantages of using R for automating the creation of Study Data Tabulation Model (SDTM) datasets. They provided a detailed guide on implementing automation techniques and sharing best practices and real-world applications to improve data management workflows with R.

These presentations underscored the R Submission Working Group’s contributions to advancing the use of R in regulatory processes promoting greater efficiency, reproducibility, and transparency in pharmaceutical data management.