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    Demonstrating Real-World Impact of Modernization of Statistical Analytics (MSA) Framework

      Demonstrating Real-World Impact of Modernization of Statistical Analytics (MSA) Framework

      Oct 01, 2025

      Project Scope

      The PHUSE project team will extend the MSA framework by creating a reference architecture that takes into account real-world scenarios and design solutions to remediate them, ultimately providing a practical guide to building an end-to-end validated environment for regulated work. Companies seeking to build an open-source programming environment for regulatory reporting can leverage the MSA framework for guidance. However, since the framework is designed to be both flexible and extensible, implementing it may prove challenging for companies, resulting in situations where risks are not sufficiently mitigated. While the original MSA paper provided conceptual guidance, the PHUSE handover of the project will seek to provide an overview of practical implementations of the framework being applied.

      Problem Statement

      The TransCelerate MSA framework published in 2021 has completed its mission to develop a framework for building an open-source software computing environment for clinical analysis and reporting. Since TransCelerate does not sponsor building of solutions, demonstrating the use and benefit of the MSA framework with specific tools and concrete implementation steps could not be realised. A PHUSE handover of the project grants the opportunity to look at real-world solutions and implementations.

      Project Leads

      Email

      Benjamin Chiang, Sanofi

      benjamin@exchange11.com

      Alex Pearce, PHUSE Project Assistant

      alexandra@phuse.global

      CURRENT STATUS (Updated Quarterly) 

      • Three technical/business use cases detailed and analysed​
      • Defined approach for describing/visualising MSA impact and reference architecture​
      • MSA to use case mapping analysis (business and technical) for one use case​
      • Finish data flow analysis for all use cases​
      • Open source options for full pipeline​
      • Implement proposed open source options – based on available resources​
      • Test and document results​
      Objectives & DeliverablesTimelines
      White PaperQ1 2025
      , multiple selections available,
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