Emerging Trends & Innovation – Project Volunteer Board
Welcome! |
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Interested in joining one of the Emerging Trends & Innovation Working Group Projects? The projects below welcome new volunteers. |
Integration of Omics data into Clinical Drug Development – Started Q1 2025 | |
Project Description:
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Key Skills:
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Investigating the Use of FHIR in Clinical Research – Started Q1 2021 | |
Project Description: Increasing interest in eSource keeps the issue of data integration between Research Systems (EDC, CTMS, CDMS, etc) and healthcare systems (EHR, etc) as a consistent want for Sponsors of Clinical Investigators and Regulators. Previous efforts to make this a repeatable, scalable solution have not met with wide-scale adoption, for a variety of reasons. Some common historical points of view have included:
Many of these issues are on the path to being resolved; government programs have pushed the adoption and accessibility of electronic health records. In addition, there are a number of stakeholders in the Research Industry that are making the use of healthcare resources a priority for the future; examples include Transcelerate eSource initiative and HL7 Vulcan Accelerator. | Regular Project Meeting Day/Time:
Key Skills: As a combination business and technical group we value input from all parts of the process of data management in Healthcare and Clinical Research. Specific skills that would benefit us include:
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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:
Key Skills:
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The Use of Git in Statistical Programming – Started Q1 2025 | |
Project Description: What features are most beneficial to stat programming? What are the benefits of Git? There is interest across the pharmaceutical industry in using Git for statistical programming. Some companies have already incorporated Git, or are attempting to, and there are common challenges being faced. In these cases, the introduction of Git has increased the complexity of a statistical programmer’s tasks, which has led to challenges in uptake and to taking advantage of the benefits Git offers. This is an important challenge to overcome for increasing efficiency of operations. The purpose of this Working Group project is to provide the industry with tools and guidance for addressing and overcoming this common challenge. | Regular Project Meeting Day/Time:
Key Skills:
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