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PHUSE collaborations are organised into a number of specialist Working Groups, each with a broad topic area. The Working Groups have specific projects designed to achieve a set of particular objectives. This page will highlight the latest news and information from our projects. Participation is open to anyone who wants to contribute and if you would like to get involved, please email workinggroups@phuse.global. |
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Working Group Q4 Reports |
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The Working Groups quarterly report is now live! These reports highlight the fantastic progress across our projects, featuring key achievements and the exciting work still underway. Explore the complete reports to see how each project is driving innovation and impact. Revisit the events from this quarter and explore what’s coming up next. |
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Real World Evidence |
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Community Forum: |
The Causal Roadmap,Targeted Learning and TMLE: What Is That All About? 29 January 2026 at 10:00-11:00 ( |
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Data Visualisation & Open Source Technology | ||
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Working Group Webinar: Exploring the Synergy of Generative AI and the Teal Framework in Pharma 10 October at 10:00-11:00 (EDT) / 15:00-16:00 (BST) / 16:00-17:00 (CEST)
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Optimizing the Use of Data Standards |
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The SDTM ADaM Implementation FAQ project within the Optimizing the Use of Data Standards Working Group has published a new response to a question regarding SDTM/ADaM IG Nuances. View the team's response to the following question here. 'Please confirm instances that would define the OCCDS analysis dataset to be the Adverse Event sub-classification.' Do you have a SDTM ADaM Implementation question? You can send your questions to the team by emailing workinggroups@phuse.global. |
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Data Transparency
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Data Transparency |
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The Rare Disease/Small Population Data Sharing project within the Data Transparency Working Group has published a new White Paper. The purpose of this White Paper is to review potential barriers to the sharing of rare disease data, such as risk of re-identification and invasion of privacy (balanced against maintaining data utility), to understand if and how these barriers apply to controlled access data sharing under specific contextual assumptions. |
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Emerging Trends & Innovation – Calling for Feedback
Nonclinical Advance Event | ||
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The Nonclinical Topics Working Group is excited to announce a multi-day virtual event coming 10–12 February 2026 at 09:00–11:30 (EST) / 14:00–16:30 (GMT) / 15:00–17:30 (CET) We have an exciting agenda of expert presentations, interactive breakout sessions and project updates, spread across three days. The event will focus on four core themes – new approach methodologies (NAMs), nonclinical predictive modelling, machine learning and PHUSE project contributions and developments – and enable attendees to explore each topic in depth with leaders from industry, regulatory agencies and the wider PHUSE Community. Full agenda and registration details coming soon!
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Data Transparency Autumn Event – Save the Date |
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We’re looking forward to welcoming you back as the Data Transparency Working Group returns with another multi-day virtual event, taking place 15–17 September 2026. Stay tuned for more details and registration information coming soon! |
Real World Data Autumn Event – Save the Date |
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We’re pleased to announce that the Real World Evidence Working Group will be holding its second multi-day virtual event from 30 September–1 October 2026. Stay tuned for more details and registration information coming soon! |
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QC Workflow Optimisation |
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The QC Workflow Optimisation project within the Emerging Trends & Innovation Working Group |
This paper sets out guidance on developing effective cloud exit strategies in the regulated life sciences industry. It explores how organisations can safeguard data security and integrity, maintain business continuity, meet compliance requirements, manage risks, and prevent vendor lock-in. By planning ahead, companies can stay resilient, flexible, and prepared for both planned migrations and unexpected provider changes.
Please provide your comments by emailing workinggroups@phuse.global. Closing date for comments: 10 October
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Real World Evidence: Call For Volunteers
The goal of this project is to develop a comprehensive, cross-disciplinary resource to support individuals and organisations in applying advanced privacy-preserving techniques to real-world data (RWD). Given the evolving landscape of privacy regulations and the increasing complexity of data sources – including integrating machine learning (ML), artificial intelligence (AI) and large language models (LLMs) into healthcare pipelines – this project will serve as a critical foundation for advancing privacy-preserving data integration frameworks for RWD.
If you would like to volunteer or learn more about this project, email workinggroups@phuse.global. Closing date: 7 October.
The Kick-Off Meeting for this project will be held on 8 October at 9:00-10:00 (EST) / 14:00-15:00 (BST) / 15:00-16:00 (CEST)
Real World Evidence: Call For Co Lead
We’re looking for a Working Group Lead for our Real World Evidence Working Group.
Working Group Scope
TheReal World Evidence Working Group aims to support, address and answer pertinent questions around real-world evidence. The Working Group is dedicated to sharing across the PHUSE Community (through Community Forums) and aligning on the best industry practices. Some of the questions we intend to address are:What are the requirements, technologies and processes needed to use real-world evidence as a source for data analysis?
What are the requirements, technologies and processes needed to incorporate real-world evidence into clinical trials?
What are the requirements, technologies and best practices needed to support the use of real-world evidence as part of regulatory submissions?
Current Projects
Applying Advanced Data Privacy Methods to Real World Data (RWD)
Missing Data Imputation in RWD Exploration of Multiple Techniques on Open-Source Data
Using OMOP and Other Real World Data Standards to Support Regulatory Submissions
Working Group Lead Roles and Responsibilities
You can learn about the role and the responsibilities here. If you are interested in this role or have any questions, workinggroups@phuse.global. Closing date: 7 October.
have published a survey exploring the current state of Quality Control across the industry. This survey aims to capture an industry-wide view of current Quality Control practices, how they may need to evolve, and the potential role of emerging technologies such as AI. Your input will help shape future PHUSE discussions, highlight areas for improvement or standardisation, and guide next steps for the QC Workflow Optimisation project. The survey will remain open from 3 December – 13 January. All responses will be collected anonymously.
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The Value of Plain Language Summaries of Trial Results (PLSs) project team within the Data Transparency Working Group, is calling for volunteers! This project has been initiated because whilst the industry has put significant efforts into developing and disseminating plain language summaries of trial results (PLSs) to promote transparency and engagement, there remains a gap in quantitative evidence of how these documents are used and what value they bring to the trial participants and the general public. Gathering feedback from trial participants – the primary audience for PLSs – and other readers will provide meaningful insights into their value and inform improvements. The team will be creating a survey to evaluate the value of PLSs and the survey feedback will be shared as a white paper authored by the group. If you’d like to become a valued project member, please get in touch with workinggroups@phuse.global by 19 January 2026 ahead of the kick off meeting scheduled for Tuesday 20 January 08:00 EST / 13:00 GMT / 14:00 CET. |
If you would like to get involved in a PHUSE Working Group Project, please explore the projects via the Volunteer Board and contact the PHUSE Office on workinggroups@phuse.global to express your interest. |
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Working Group Report: Includes project updates, recent and upcoming deliverables and future plans for each Working Group. | |
Monthly Mailings: The monthly newsletter. Here you will find a full update from each month of the year, easily accessible and divided into key areas of PHUSE. | |
PHUSE Blogs: Fancy a quick read? A blog is a perfect way to catch up on all things Working Groups. Get the lowdown on the latest events from across the globe and stay updated on industry topics brought to you by industry professionals. |
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Initiate and lead a new project under the PHUSE Working Groups umbrella. The new project must address problems of significant relevance to computational science related to drug, biological and device development and must meet all of the guidelines for projects within the collaboration, including the following mandatory requirements:
New projects can be submitted anytime during the year, click here to submit. |