Episode Summary

In this episode of the Verisian Community Podcast, Katja explores the huge potential of open-source tools in clinical development. She discusses how platforms like OpenStudyBuilder are revolutionizing study design and collaboration within the pharma industry. Katja shares her experiences in overcoming resistance to open-source adoption, addressing challenges like regulatory constraints and industry skepticism. The conversation delves into the evolving role of traditional tools like SAS alongside modern languages such as R and Python. Katja closes with a forward-looking vision for how open-source technology can reshape the future of clinical development and regulatory submissions over the next decade.

Biography Katja

As open source consultant, Katja hosts a portal about open-source solutions for Pharma (www.glacon.eu/portal) and provides open-source consulting. Her key experiences are SAS, Web Technologies, ADAM, Define.xml and the TLF generation where she worked for several years at Bayer. Additionally, she is the community manager for the OpenStudyBuilder open source project, is a board member of the CDISC Open Source Alliance and part of the PHUSE Open Source Technology in Clinical Data Analysis Board.

Resources

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