GSK’s Journey to Clinical Study Reporting Using Open Source chronicles the transformation of clinical reporting at GSK, the presentation marks pivotal moments in the pharmaceutical industry’s evolution—from the proprietary, SAS-dominated era of the 1980s and 90s, through the pain of rising R&D costs and global health crises, to the emergence of collaborative models and open-source innovation.

The story highlights how industry challenges catalyzed a shift toward openness and collaboration. Key milestones include the FDA’s clarification on software neutrality, the rise of R and open-source platforms, and GSK’s commitment to writing at least 50% of code in open-source languages. The COVID-19 pandemic accelerated this transformation, driving rapid adoption of data science platforms and collaborative tools.

GSK’s multi-wave approach to change is shared and candidly addresses ongoing challenges: technical validation, regulatory uncertainty, cultural resistance, and the need for robust governance and training.

Ultimately, the journey demonstrates that embracing open-source technologies enables greater automation, and innovation in clinical study reporting. Success depends on a growth mindset, adaptability, and a vision for collaborative transformation—qualities that GSK continues to foster as it leads the industry into a new era of transparency and shared progress.
Sam Warden | Tim Colman
GSK | GSK
Sam Wardens Keynote (APAC Replay)
GSK’s Journey to Clinical Study Reporting Using Open Source chronicles the transformation of clinical reporting at GSK, the presentation marks pivotal moments in the pharmaceutical industry’s evolution—from the proprietary, SAS-dominated era of the 1980s and 90s, through the pain of rising R&D costs and global health crises, to the emergence of collaborative models and open-source innovation.  The story highlights how industry challenges catalyzed a shift toward openness and collaboration. Key milestones include the FDA’s clarification on software neutrality, the rise of R and open-source platforms, and GSK’s commitment to writing at least 50% of code in open-source languages. The COVID-19 pandemic accelerated this transformation, driving rapid adoption of data science platforms and collaborative tools.  GSK’s multi-wave approach to change is shared and candidly addresses ongoing challenges technical validation, regulatory uncertainty, cultural resistance, and the need for robust governance and training.  Ultimately, the journey demonstrates that embracing open-source technologies enables greater automation, and innovation in clinical study reporting. Success depends on a growth mindset, adaptability, and a vision for collaborative transformation—qualities that GSK continues to foster as it leads the industry into a new era of transparency and shared progress.