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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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Risk Based Quality Management
The End to End RBQM Education project is hosting a new webinar: Decoding AI in Clinical Trials: Practical Applications, Regulatory Reality, and the Road Ahead.
This webinar offers a practical, reality-check view of how AI and large language models are being applied in clinical trial conduct today. It explores real-world use of AI in RBQM, regulatory and compliance considerations, and what generative AI can (and can’t) deliver. Helping organisations prepare for what’s coming over the next 3–5 years.
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Real World Evidence | ||
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Community Forum: Capturing the Patients Voice Through Lived Experience Across Diaries and Social Media 23 April 9:00-10:00 (EDT) / 14:00-15:00 (BST) / 15:00-16:00 (CEST)
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Data Transparency Autumn Event – |
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Call For Speakers |
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The Data Transparency Working Group invites abstract submissions for its upcoming multi‑day virtual event, taking |
place 15–17 September 2026 |
at 10:00–12:30 (EDT) / 15:00–17:30 (BST) / 16:00–18:30 (CEST). The event will focus on the evolving landscape of clinical data transparency, including approaches to data sharing, anonymisation, governance and enabling responsible access to clinical data. Focus your submission on these central themes and submit an abstract by 8 May to contribute to the discussion. Click here for more information.
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Real World Data Autumn Event – |
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Call For Speakers |
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We’re |
excited to announce |
Call for Speakers for the Real World Evidence Working |
Stay tuned for more details and registration information coming soon!
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Optimizing the Use of Data Standards
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‘CTCAE Upversioning – When should a sponsor organisation decide to upversion CTCAE, DAIDS, or any other toxicity grading standards? How should sponsors handle pooled analyses with varying grading scales?'
Do you have a (FAQ project based) question? Send your questions to the team by emailing workinggroups@phuse.global.
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Group’s second multi‑day virtual event is now open! Taking place 30 September – 1 October 2026, from 09:00–11:30 (EDT) / 14:00–16:30 (BST) / 15:00–17:30 (CEST). Submit your abstract by 8 May for the chance to present. Focus your submission on these central themes:
Click here for more information.
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Emerging Trends & Innovation |
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The Integration of Omics Data into Clinical Drug Development project within the Emerging Trends & InnovationWorking Group has published a new |
White Paper titled “Capturing Computational Workflows in Clinical Trials with |
BioCompute” This white paper explores how the BioCompute |
The team welcome feedback on the paper by 6 March . Please send responses to workinggroups@phuse.global.
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PharmaForest: A Collaborative Repository of SAS Packages for Pharmaceutical Industry project team within the Data Visualisation & Open Source Technology Working Group, is calling for volunteers!
PharmaForest is a collaborative initiative focused on improving how SAS programming is developed and shared across the pharmaceutical industry. Built on the SAS Packages Framework (SPF), it promotes reusable, standardised SAS packages to reduce duplication, improve efficiency, and support compliance.
By combining an open package repository with community collaboration and practical guidance, PharmaForest helps move SAS programming from siloed approaches to a more scalable, industry-wide model.
If you’d like to become a valued project member, please get in touch with workinggroups@phuse.global by 9 March ahead of the kick off meeting scheduled for Tuesday 10 March 08:00 EST / 13:00 GMT / 14:00 CET.framework can transform the way computational workflows are captured and communicated in clinical trials. As bioinformatics analyses become increasingly complex, consistent and transparent documentation is essential for reproducibility and regulatory confidence. Through practical case studies, the paper demonstrates how BioCompute enables structured, auditable workflows across diverse data types, including omics and imaging, while supporting more efficient collaboration and regulatory submissions. |
Real World Evidence |
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The RWD Guideline for Programming and Analysis Processes Project within the Real World Evidence Working Group has published a new White Paper. This paper offers practical guidance for statistical programmers on applying real‑world data (RWD) to produce regulatory‑grade real‑world evidence (RWE), covering study design, data fitness, governance, ethics, vendor engagement, bias management, and regulatory submission considerations. |
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Real World Evidence – Calling For Feedback |
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The Quality and Reusability of Real World Data Project within the Real World Evidence Working Group has produced a White Paper ‘Real-World Data Reliability and Integrity: Ensuring Real-World Data is Fit for Use for Regulatory Submissions’. This White Paper focuses on the usability of real-world data sources for regulatory submission purposes. To assess the fit for use of this data, we need to assess the relevance and the reliability of the data. Please provide your comments by emailing workinggroups@phuse.global. Closing date for comments: 24 April 2026. |
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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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