Content Comparison

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)

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!

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

The Enhanced Risk-based Quality Management (RBQM) Approaches for First-in-Human and/or Small Clinical Trials project within the Risk Based Quality Management Working Group have published a new white paper: Industry recommendations for Risk Based Quality Management in First in Human and Small Clinical Trials which is now open for public review.

The purpose of this white paper is to provide guidance on the application of Risk-Based Quality Management (RBQM) in First-in-Human (FIH) and small clinical trials. This document aims to support sponsors in adopting risk-proportionate, efficient quality oversight approaches while maintaining patient safety and data integrity. It is intended for clinical operations, quality, and oversight teams involved in the design, conduct, and monitoring of small clinical trials.

The team welcome feedback on the paper from 9 January – 6 February. Please send responses to workinggroups@phuse.global

The Anonymization of Imaging Data project within the Data Transparency Working Group have published a new white paper: Imaging Data Anonymization Guideline which is now open for public review.

The purpose of this guideline is to define the minimum anonymization standards for DICOM imaging data shared externally via a secure, governed research environment (SGRE). This document aims to ensure that all shared clinical trial imaging data complies with privacy regulations and ethical standards, thereby protecting the identities of clinical trial participants. It is intended for people involved in data processing, anonymization, and external collaborations, as well as for external researchers who will access these anonymized data.

The team welcome feedback on the paper from 6 January – 3 February. Please send responses to workinggroups@phuse.global

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 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.

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.