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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. |
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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, |
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please email workinggroups@phuse.global. |
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Projects Calling for Participants
Email workinggroups@phuse.global to get involved
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Central Monitoring Capabilities – Members
Central Monitoring is an emerging field with an unclear scope, goals and roles. Central Monitoring, if executed appropriately, can have a positive impact on data quality, patient safety and clinical trial efficiencies. Strong Central Monitoring practices can support risk reduction and through important trend analysis and mitigation, decrease preventable errors that can have an impact on patient safety or clinical trial conclusions.
This project will work to define Central Monitoring (including differentiating from data management and other forms of data surveillance), suggest success measures and best practices to ensure a well-connected end-to-end component of quality risk management. The project will provide insight and guidance to address understanding as well as the current and future needs of holistic Central Monitoring process and capabilities. The approach the project intends to take will encourage exploration of different approaches versus recommendations as not deter sponsor innovation (e.g - points to consider).
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End-to-End Open–source Collaboration Guidance– Members
The use of open-source languages continues to increase in clinical reporting. This has helped shift pan-industry collaborations to move beyond the traditional domain of collaboration on statistical packages. Within multiple companies, we are seeing a shift where individuals may, as part of their role, contribute primarily to projects in the open-source setting. Numerous collaborations exist, with several coalescing under an umbrella collaboration called the pharmaverse. However, there remains a lack of understanding within companies around the benefits and risks of open sourcing.
This project is led by two presenters from the PHUSE CSS 2021 open-source panel and continues on from discussions and points at that event. The primary aim of the project is to provide guidance, collaboration and creation of open-source projects, as well as to link out to more information. If gaps are found, they will be noted for later follow-up and potential follow-on projects.
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Data Standards Implementation Governance Survey
The Best Practices in Data Standards Implementation Governance project has put together a survey to gather an insight into how organisations are currently governing data standards, including what level of governance exists, the scope of standards governed, how governance is organised, and what are the particular challenges and pain points organisations are experiencing when implementing and governing the standards. We seek responses from anyone who is involved in data standards governance or is a user of data standards, from any functional role. The data from the survey will be used to make recommendations on best practices for data standards governance implementation and to develop further projects for particular areas which are found to be the most challenging.
The closing date for this survey is 7 March.
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The Analyses & Displays for Laboratory Data team have been collaborating on a White Paper which provides updated recommendations for tables, figures, and listings (TFLs) used to analyse and display laboratory measurement with a focus on Phase 2-4 clinical trials and integrated summary documents. The White Paper is intended to provide advice to sponsors who are developing the analysis plan for Phase 2-4 clinical trials and integrated summary documents, or other documents in which analysis of laboratory measurements are of interest. Although the focus of this White Paper is on study level Phase 2-4 clinical trials and integrated analysis for regulatory submissions, some of the content may apply to Phase 1 studies, ongoing aggregate safety evaluations, or other types of medical research such as observational studies.
The team are calling for public feedback on the White Paper, please submit feedback to workinggroups@phuse.global by 11 March.
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PHUSE Working Group Co-Lead |
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Are you passionate about data standards and excited by the potential of emerging technologies to optimise their implementation? PHUSE is seeking a motivated and collaborative Co-Lead to help guide the Optimizing the Use of Data Standards Working Group. This is a unique opportunity to shape impactful industry initiatives, work with global experts, and drive innovation in data standards. As a Working Group Co-Lead, you will play a central role in driving the success of multiple projects aligned with advancing the use of data standards. You will collaborate closely with Project Leads, the PHUSE Office, and leadership committees to ensure initiatives are well defined, well supported, and delivered effectively to the broader community. We encourage applications from individuals who:
For more information, visit Optimizing the Use of Data Standards or contact workinggroups@phuse.global. To apply, please send a brief summary of interest and your qualifications to workinggroups@phuse.global by 3 July. |
PHUSE Working Group Project Co-Lead |
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The Optimizing the Use of Data Standards Working Group is seeking a Co-Lead to oversee maintenance of the SDSP (Study Data Standardization Plan) package under the Management of ODS Regulatory Referenced Deliverables (MRRD) project. Co-Leads will work under guidance of the MRRD Project Lead and are asked to serve two years in the role. Responsibilities include:
For more information, go to Management of ODS Regulatory Referenced Deliverables or contact workinggroups@phuse.global. To apply, please send a brief summary of interest and your qualifications to workinggroups@phuse.global by 14 July. |
The SEND Industry Feedback Survey project, under the Nonclinical Topics Working Group, is looking for volunteers to support this exciting initiative. This project will help gather valuable industry insights and feedback to support future discussions and improvements within the SEND space. If you are interested in contributing, collaborating with peers, and helping shape this project, we’d love to hear from you. Find out more information about the project on the Volunteer Board. To get involved, please complete the New Member Onboarding Form.
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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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Real World Evidence | ||
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Community Forum: Real World Evidence Meets AI and Privacy 9 July 9:00-10:00 (EDT) / 14:00-15:00 (BST) / 15:00-16:00 (CEST)
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pharmaverse | ||
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Hackathon: pharmaverse Hackathon series featuring the {aNCA} package 9, 16 & 23 July 9:00-10:00 (EDT) / 14:00-15:00 (BST) / 15:00-16:00 (CEST)
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The Data Transparency Working Group is preparing 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.
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The Real World Evidence Working Group is preparing for its upcoming multi‑day virtual event, taking place 30 September–1 October 2026 at 09:00–11:30 (EDT), 14:00–16:30 (BST), and 15:00–17:30 (CEST). Join the PHUSE Community to explore the evolving landscape of real-world data (RWD), including its growing role in clinical research and regulatory decision-making. This event will bring together global experts to share insights, practical approaches, and real-world applications of RWD.
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Risk Based Quality Management |
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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 has published a new White Paper. This paper provides practical recommendations for applying risk‑based quality management (RBQM) in small and early‑phase clinical trials, covering quality‑by‑design principles, risk assessment using critical‑to‑quality factors, targeted monitoring strategies, and approaches to overcome adoption challenges, while ensuring participant safety and regulatory compliance. |
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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 |
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address problems of significant relevance to computational science related to drug, |
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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 |
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Have you attended a PHUSE Webinar Wednesday?
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to submit. |