#007 How Open Source and Community Efforts Drive R-Based FDA Submissions

#datascience #dataanalysis #technology #datascience #opensource #pharmaverse #pharma #dataanalysis #clinicaltrials

In this episode, Ben Straub, Principal Programmer at GSK, explores the shift from proprietary software to open source tools in the pharmaceutical industry. He shares insights into regulatory challenges, the rise of R, and the impact of {admiral} and other open-source packages on clinical data analysis and submissions. From pilot programs to enterprise-wide adoption, learn why collaboration is key to reducing risk and shaping the future of regulatory workflows.

In this episode, you will learn:

• Lessons learned from GSK’s open source adoption journey,
• How collaboration via pharmaverse, PHUSE, and R Consortium accelerates regulatory submissions
• How {admiral} package for ADaM datasets was one of the triggers for widespread open source adoption in pharma
• Why R is a dominant language in pharma
• What are the next milestones to modernize outdated regulatory standards

Webinar about GSK's R Journey: From Pilot Projects to Enterprise Adoption: https://www.youtube.com/watch?v=xDrt6txplek
Admiral package: https://pharmaverse.github.io/admiral/ __________________________________________
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Appsilon empowers pharmaceutical and life sciences companies to leverage open-source technology for faster, data-driven decision-making in regulated environments.
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