Emerging Trends & Innovation – Project Volunteer Board
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Interested in joining one of the Emerging Trends & Innovation Working Group Projects? The projects below welcome new volunteers. |
Project Description: This project aims to advance the adoption of omics data in clinical drug development by addressing key challenges in data integration, quality, analysis and standardisation. Current limitations, including the inability of CDISC standards to fully accommodate complex omics data types and workflows, highlight the need for complementary approaches. The project will focus initially on the implementation of the BioCompute standard, developed in collaboration with the FDA to document bioinformatics workflows. Activities will include defining best practices, developing guidance for creating and validating BioCompute Objects, and outlining submission considerations. The project will also support knowledge sharing and community engagement to improve understanding and adoption. In the longer term, the initiative will explore broader topics such as data integration frameworks, regulatory guidance, quality control, and training. Establishing this Working Group early will support consistent adoption, provide industry feedback and help prepare for increasing regulatory use of omics data. | Regular Project Meeting Day/Time:
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Project Description: 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. | Regular Project Meeting Day/Time:
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Project Description: This Working Group project aims to support the pharmaceutical industry in adopting Git for statistical programming by identifying the most beneficial features and addressing common challenges. While interest in Git is growing and some organisations have begun implementation, uptake remains inconsistent due to the added complexity it introduces to established workflows. The project will provide practical guidance, tools and examples to help statistical programmers understand and effectively use Git, enabling them to realise its benefits in areas such as version control, collaboration and traceability. By reducing barriers to adoption and clarifying how Git can be integrated into existing processes, the initiative seeks to improve efficiency, consistency and confidence in its use across the industry. | Regular Project Meeting Day/Time:
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