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Working Groups Hot Topics

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, email: workinggroups@phuse.global.

Data Transparency Summer Event 2022

Data Transparency Summer Event: Registration is now open! Click here to secure your place at the world’s largest home for data transparency events.

CSS 2022

CSS: Registration now open! Click here to register before 1 July to benefit from the discounted Early Bird rate.

Real World Evidence Community Forum 

The Role of the Statistician and Statistical Programmer in Real-World Data Analysis: Real World Evidence presents the next PHUSE Community Forum, taking place 6 July, 15:00 (BST)/ 10:00 (EST). This meeting will start with a 30-minute presentation focused on the changes necessary to use real-world data followed by a forum discussion on how this affects the role of the statistical programmer and the statistician. If you are interested in attending this event, register here. 

Projects Calling for Members

For more information on the PHUSE Working Groups and their projects, click here. If you would like to become a valued member of PHUSE and volunteer for one or multiple projects, please email: workinggroups@phuse.global. 

Recently Published Deliverables
If you wish to view the extensive list of all PHUSE published deliverables, click here. 
Bio-research Monitoring Data Reviewers Guide (BDRG) – The Optimizing the Use of Data Standards Working Group and the PHUSE BIMO Project Team are pleased to announce the publication of the Bio-research Monitoring Data Reviewer’s Guide (BDRG) Package. This reviewer’s guide was created to provide the industry with a consistent way and usable format for communicating information concerning the Bio-research Monitoring (BIMO) data to regulatory agency reviewers. The BDRG package includes an Introduction and Overview, Template, Completion Guidelines and 3 Examples.
Project Idea?

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 for template and submission.


Working Groups Latest Report: Q12022

This Report provides a detailed overview of the projects progress this past quarter.


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