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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.

Optimizing the Use of Data Standards project, Implementation of Estimands (ICH E9 (R1)) using Data Standards has produced a White Paper, which is now out for public review. This paper provides recommendations to facilitate the implementation of the estimands framework introduced by the ICH E9(R1) within the data flow, promoting alignment across the industry. These consist of best practices for using existing standards and extensions to data standards where applicable and are illustrated by examples, in scope where an impact assessment on Data Collection (CDASH), Data Tabulation (SDTM), Data Analysis (ADaM) and the Data Reviewers Guides (cSDRG and ADRG).

White Paper and Appendix (please note, there might be some visual issues with some of the tables, these will be corrected during the final editing stages for publication). Closing date: 17 January.

Please share any comments and thoughts via email, at workinggroups@phuse.global. Feedback will be shared with the project team to help them develop the final White Paper.

Data Visualisation & Open Source Technology Working Group's project, Julia Initiative for High-Performance Computing has published their White Paper 'Julia for High-Performance Computing'. This White Paper provides 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. It also discusses current real-world use cases of Julia and potential case studies for high-performance computing, along with recommended readings and references for further exploration. Please head over to our PHUSE website to read!

The Cloud Adoption in the Life Sciences Industry project within the Emerging Trends and Technologies Working Group have published their white paper 'Cloud Framework, Pre-Amble', This paper explores adopting cloud-based solutions for GxP workloads, understanding why the essential characteristics of cloud services and solutions are important for determining the applicability of GxP requirements to specific Cloud Service Providers and/or cloud-based solution models.

The Real World Evidence Working Group have been hosting a webinar series which will be continuing into 2024. The next upcoming webinar RWD Quality Challenges – Different Perspectives will be taking place on 18 January 2024 – 14:00–15:00 (GMT) 09:00–10:00 (EST). This webinar will be on the topic of Real World Data Quality challenges, looking at different perspectives from Dr Cheryl Grandinetti from the FDA and Kris Wenzel from MMS Holdings.

Register here now! 

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, biological 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.