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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.

The Safety Analytics Working Group will be delivering a series of virtual, free to attend webinars over the coming months. The second webinar took place on 13 July on the topic of Overall Safety Assessment – Standard Safety Tables and Figures. Click here to view the slides! A list of all upcoming webinars can be found here. 

The Real World Evidence Working Group hosted a Community Forum on Designing your RWD Study: Is Your Data Fit For Purpose? Rest assured if you couldn't attend, the recording is available to view now!

Real World Evidence Working Group’s new project Real World Data Guideline/White Paper for Statistical Programmers is now calling for volunteers. The aim of this project is for statistical programmers across pharma to collaborate and provide their input to create an RWE Guideline/White Paper for the industry. 

Please contact workinggroups@phuse.global to register your interest in volunteering.

The Cloud Adoption in the Life Sciences Industry project have made an update to their Cloud Framework, Pre-Amble White Paper. Since the original publication of this framework, adoption of the public cloud by Life Sciences has become necessary, and no longer the exception. As part of this foreseeable evolution, there has been a significant rise in the construction of hybrid and/or multi-cloud systems. This framework outlines these approaches leveraging well recognised concepts. The team are calling for feedback on the White Paper, please provide any comments to workinggroups@phuse.global by 23 August. 

The Julia Initiative for High Performance Computing project have produced a White Paper providing an overview of Julia's features and benefits for high performance computing, including its fast compilation, dynamic typing, multiple dispatch, and built-in support for parallelism. This paper also discusses current real-world use cases of Julia and potential case studies for high performance computing. The team are calling for feedback on the White Paper, please provide any comments to workinggroups@phuse.global by 7 August. 

The Centralised Monitoring Capabilities Project has produced a White Paper focusing on the value of CM as it relates to the protection of data integrity and quality. This paper also explores the subsequent considerations and challenges in demonstrating this value and has leveraged the industry survey conducted by the Project – exploring case studies and review of industry literature. The team are calling for feedback on the White Paper, please provide any comments to workinggroups@phuse.global by 28 July. 

The Bio-research Monitoring Data Reviewer's Guide project has updated their Data Reviewer’s Guide Template (BDRG). Version 3.0 of the BDRG provides regulatory agency reviewers an orientation to the submitted Bioresearch Monitoring (BIMO) data in a consistent way and usable format. The BDRG Package includes an Introduction and Overview, Template, Completion Guidelines and Examples. 

The Comparing Analysis Method Implementations in Software (CAMIS) Project has published their White Paper titled 'Key Considerations When Understanding Differences in Statistical Methodology Implementations Across Programming Languages – An Introduction to the CAMIS Project'. This White Paper aims to empower clinical data scientists to make informed choices on the implementation of statistical analyses when multiple languages yield different results. 

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, biologic 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. 

Working Groups Report: Includes project updates, recent and upcoming deliverables and the 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.