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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 Cloud Adoption in the Life Sciences Industry project, within the Emerging Trends & Technologies Working Group, has recently published an updated version of the Cloud Audit Activities which makes up part of the Cloud Framework Documents. The framework for cloud adoption consists of different papers. The paper related to the assessment/audit of cloud service providers has been updated to reflect current thinking. This includes more focus on assessment rather than physical audits. View the paper here. 

The SDTM ADaM Implementation FAQ project, part of the Optimizing the Use of Data Standards Working Group, has published two new responses to questions they received under SDTM/ADaM IG Nuances and Data Submissions. The questions are in relation to submitting a custom ADaM dataset and transgender patients in clinical trials. 

The Office of New Drugs (OND) in the FDA Center for Drug Evaluation and Research (CDER) released two documents in early September for public review, on standard adverse event groupings and queries for evaluation of biologic/new drug applications. The Safety Analytics Working Group are still seeking members to join their brand-new project which aims to provide consolidated feedback on these documents.
There is only 1 week left to provide your comments as all feedback will need to be collected by 24 October to submit to the FDA! For more information on how to get involved, please email workinggroups@phuse.global.

BIMO FAQ – It was apparent during the creation of the PHUSE Bioresearch Monitoring Data Reviewer's Guide (BDRG) that organisations implementing BIMO Submission packages have outstanding questions. The aim of this project is to develop a BIMO Frequently asked Questions Forum on the PHUSE Advance Hub. The forum will utilise the questions brought forward by the pharma/CRO community via public review, presentations, PHUSE BIMO team members, etc...
To get involved, please contact workinggroups@phuse.global. 

Best Data Practices for Rare Disease Patient Foundations and Researchers, part of the Emerging Trends & Technologies Working Group, is looking for members to join their project to create a guidance about best data practices for patient foundations and for researchers in the form of decision trees, graphics, short printable materials or videos. Please contact workinggroup@phuse.global for more information. 

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 Latest Report Q2 2022: The report includes project updates, recent and upcoming deliverables and the future plans for each Working Group.

Monthly Mailings: Our monthly newsletter. Here you will find a full update from each month of the year, easily accessible and divided into key areas of PHUSE.