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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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In its 14th year, the PHUSE/FDA Computational Science Symposium (CSS) will be expanding its global reach! In addition to Silver Spring, Maryland, we will be running a simultaneous event in Utrecht, the Netherlands!
Mark Your Calendars!
The US event will be in Silver Spring, Maryland 19-21 May, and the EU event will be in Utrecht, the Netherlands 20-21 May.
Please visit the PHUSE website for more information.
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RWD Sources – How the Genesis of Your Data Determines What Questions You Can Answer.
When considering sources of RWD, it is important to consider more than just the number of available patients. Recently released guidance from the FDA encourages researchers to build accurate, complete and traceable real-world datasets. Combining data from structured and unstructured electronic health record data, closed claims, and other sources is essential to building the patient journey.
In our October Community Forum, we will explore two different angles of RWD sourcing from the provider’s point of view:
- Tim (Verantos) will share with us novel insights into unstructured data and examples of the value that can be leveraged from such data.
- Matt (Azimuth) will share with us details and example analyses of a unique research data source derived from linking claims and EHR data hosted by the Department of Defense network.
Come and join us for what promises to be another very interesting Community Forum!
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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) / |
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Data Transparency |
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Autumn Event |
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– Call |
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Taking place virtually 4-6 February, this event presents an incredible opportunity to showcase your ideas, share insight and engage with a vibrant community dedicated to advancing data transparency in the industry.
For the chance to make a lasting impact, within a diverse network of like-minded individuals, submit your 150-word abstract before 15 November 2024.
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Also coming in 2025 is the Data Transparency Autumn Event 16-18 September 2025.
Watch out for announcements early in 2025!
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The Management of ODS Regulatory Referenced Deliverables project within the Optimizing the Use of Data Standards Working Group has provided an update to two of its regulatory-referenced deliverables, the ARDG Template and the cSDRG Template. You can learn more about this project and view the previous templates for the referenced deliverables here.
Please provide your comments by emailing workinggroups@phuse.global. Closing date for comments: 30 October.
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The Nonclinical Topics Working Group has just formed a new project titled Developing Predictive Models to Facilitate Interpretation of Toxicology Study Results which is now calling for volunteers.
A computational pipeline to build models to predict target organs of toxicity from SEND datasets has been developed and published on GitHub under PHUSE. Project team members will evaluate the feasibility and performance of this pipeline when run on data from within their organisations. The pipeline will be updated to improve compatibility with different database systems, and efforts will be made to improve its performance across disparate data sources. Additional study interpretations – e.g. adversity of findings, NOAEL determination, clinical translatability, structure activity relationship – will be explored for development of predictive models. Successful modeling approaches will be published in peer-reviewed scientific journal articles.
If you would like to volunteer or learn more about this project, email workinggroups@phuse.global. Closing date: 24 October
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The Teal Enhancements for Cross-Industry Adoption, a new project within the Data Visualisation & Open Source Technology Working Group is now calling for volunteers.
Research: Conduct a detailed analysis of the current teal framework and identify areas where flexibility can be introduced. A Proof-of-Concept will be provided after research. Development: Create new functionalities that allow for the re-formatting, post-processing, and decoration of outputs generated by existing teal modules.Testing: Develop test cases to ensure the new functionalities are compatible with existing modules and meet the customisation needs of different companies.Documentation: Update the framework's documentation to include instructions on how to use the new features.Training & Support: Provide training and ongoing support to users within the pharma industry to facilitate the adoption of the enhanced teal framework.
If you would like to volunteer or learn more about this project, email workinggroups@phuse.global. Closing date: 27 October
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The Risk Based Quality Management Working Group have just launched a new project titled Enhancing the Clinical Trial Risk Assessment Process which is now calling for volunteers.
This project proposes beginning this project by identifying CtQ factors via a risk assessment process (characterising risk including assessment and mitigation/risk reduction strategies), which would include identifying trial-level QTLs that support CtQ factors.
If you would like to volunteer or learn more about this project, email workinggroups@phuse.global. Closing date: 1 November
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The Missing Data Imputation in RWD Exploration of Multiple Techniques on Open-Source Data a new project within the Real World Evidence Working Group is now calling for volunteers. The aim of this project is to publish a white paper which shall explore multiple models available for missing data imputation and share with the wider group the potential of each model and its efficiency in dealing with different kinds of missing data. The model efficiency is compared using a single open-source simulated dataset.
If you would like to volunteer or learn more about this project, email workinggroups@phuse.global. Closing date: 1 November
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The Best Practices in Data Standards Implementation Governance project within the Optimizing the Use of Data Standards Working Group has published a new white paper.
This white paper presents the results of the survey along with feedback from informal discussions at PHUSE’s Computational Science Symposium (CSS) sessions in 2022 and 2023. The data and observations shared are intended to inform industry and identify further projects for exploration while also encouraging industry collaboration for areas which are found to be the most challenging.
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Do you have a SDTM ADaM Implementation FAQ question? You can send your questions to the team by emailing workinggroups@phuse.global.
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The Japan eData Submission Working Group project have published two surveys: Data Listings in Clinical Study Reports and Real World Data (RWD). The results will be presented at the APAC Single Day Event (SDE) in Tokyo, Japan on 6 December, which will open for registration next month.
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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 – Call For Speakers | ||
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We’re excited to announce Call for Speakers for the Real World Evidence Working 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 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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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. |