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We’re excited to share the latest update highlighting the fantastic progress across our Working Groups. This quarter’s report showcases key achievements from our Projects and highlights the important and innovative work that’s still underway.

Explore the full report to see how each Project is making an impact. Don’t miss the detailed overview of the events and milestones that shaped this quarter’s journey.

pharmaverse Hackathon Series Featuring the {xportr} Package

Hackathon Kick-Off – 12 May 09:00–10:00 (EDT) / 14:00–15:00 (BST) / 15:00–16:00 (CEST)
Hackathon – 21 May 08:00–10:00 (EDT) / 13:00–15:00 (BST) / 14:00–16:00 (CEST)
Hackthon Wrap Up – 28 May 09:00–10:00 (EDT) / 14:00–15:00 (BST) / 15:00–16:00 (CEST)

Webinar: Biostatistical Considerations When Using RWD and RWE in Clinical Studies for Regulatory Purposes

21 May 11:00-12:00 (EDT) / 16:00-16:00 (BST) / 17:00-18:00 (CEST)

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.

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:

• Optimising the Generation of Real‑World Evidence with NLP & AI

• Digital Endpoints Generated from Real‑World Data

• Data Sources, Lineage and Provenance

• Vendor–Sponsor Governance and Alignment

• Any Other Theme that Tackles the Challenges in Using Real‑World Data

Click here for more information.

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.

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.

The EU CTR Implementation Project within the Data Transparency Working Group has finalised the White Paper ‘Protecting Commercially Confidential Information (CCI) While Complying with the European Union Clinical Trials Regulation 536/2014’. This White Paper offers clear, practical guidance to help clinical trial sponsors navigate the EU Clinical Trials Regulation while safeguarding commercially confidential information (CCI).

Please provide your comments by emailing workinggroups@phuse.global. Closing date for comments: 6 May 2026.

The Conformance with the tumor.xpt Specification within the Nonclinical Topics Working Group has produced a White Paper ‘Conformance with the Technical Specifications Document for Submitting Nonclinical Datasets for Evaluation of Rodent Carcinogenicity Studies of Pharmaceuticals’ along with a set of Conformance Rules. This White Paper outlines the development of standardised conformance rules for tumor.xpt datasets to enable automated validation, improve data consistency, and reduce manual effort in regulatory submissions for carcinogenicity studies..

Please provide your comments by emailing workinggroups@phuse.global. Closing date for comments: 20 May 2026.

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. 

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. 

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: 

• The projects must address significant research issues relevant to Computational Science

• The project must not attempt to address FDA policy issues

• There must be at least one Project Lead personally involved in planning and carrying out the project

New projects can be submitted anytime during the year, click here to submit

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