QC Workflow Optimisation
Problem Description |
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This Working Group project aims to evaluate the current clinical study analysis and reporting QC process, which has remained largely unchanged for decades despite recognised inefficiencies, particularly with double programming. The project will assess whether existing approaches remain fit for purpose in a modern context and identify opportunities to improve efficiency and better use programming resources. A key focus will be understanding how the QC process impacts the adoption of Git and other modern technologies, and how current expectations – including those of regulators – may influence acceptable QC practices. The project will analyse industry-wide approaches, challenges introduced by double programming, and potential alternative models. It will also explore the impact of agile methodologies, insights from other regulated industries, cost considerations, and the potential role of AI. The outcome will provide a comprehensive, evidence-based view of how QC processes can evolve to better support modern statistical programming practices. |
Project Leads | |
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Caroline Phares, Altair | |
Korak Datta, AstraZeneca | |
Nicola Newton, PHUSE Project Coordinator | nicky@phuse.global |
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