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: The Real World Evidence project, part of the Emerging Trends and Technologies Working Group, 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. |
Recommendations for SEND Dataset QC Best Practices – This White Paper provides key insights into current QC activities performed by industry as well as best practice recommendations for QC procedures. The aim is to promote more consistent QC procedures to help regulatory reviewers be more confident the SEND data accurately represents the data in the study report. |
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:
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. |