Demonstrating Real-World Impact of Modernization of Statistical Analytics (MSA) Framework
Project Description |
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The PHUSE project team will extend the MSA framework by developing a reference architecture grounded in real-world use cases. This work will identify common implementation challenges and propose practical design solutions to address associated risks, providing clear guidance for building a validated, end-to-end environment for regulated activities. While the MSA framework offers flexible, open-source guidance for regulatory reporting, its adaptability can create implementation complexity and gaps in risk mitigation. Building on the original 2021 TransCelerate framework, which established the conceptual foundation but did not include demonstrable solutions, the PHUSE handover will focus on practical application. This includes showcasing how the framework can be implemented using real tools and workflows, helping organisations move from theory to operational adoption with greater confidence and consistency. |
Project Leads | |
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Benjamin Chiang, Bristol Myers Squibb | |
Yao Lu, UCB | |
Neil Ward, Amgen | |
Nicola Newton, PHUSE Project Coordinator | nicky@phuse.global |