Content Comparison

The SDTM ADaM Implementation FAQ Project project within the Optimizing the Use of Data StandardsWorking Group is pleased to announce that all published FAQ’s are now available on the PHUSE Deliverable website. Click here to view the categories of answered FAQs. 

The SEND Industry Feedback Survey Project project within the Nonclinical Topics Working Group have published their 2025 SEND Survey, marking a significant milestone as it enters its 10th consecutive year of providing valuable industry insights.

The survey will remain open from 14 November to –3 December. All responses will be collected anonymously.

The results will be presented at the Nonclinical Advance Event 10–12 February 2026 and subsequently published on the PHUSE Archive.

The Cloud Adoption in the Life Sciences Industry Project project within the Emerging Trends & Innovation Working Group, has published a new White Paper, Cloud Services: A Framework for Adoption in the Regulated Life Sciences Industry.

This White Paper provides guidance for adopting cloud services in regulated life sciences. It explains how GxP requirements apply to cloud providers and offers a clear framework for planning and executing exit strategies to ensure data integrity, business continuity and compliance.

The Participant Data Return team has published a blog on their recent survey findings. Participant data return is the act of granting clinical trial participants access to the data that was collected about them during a clinical trial. In current clinical trial practice, we take measurements, conduct tests, and perform procedures. The results are reviewed by the investigator and stored by the sponsor, but participants rarely see their own results.

In spring 2025, PHUSE established the Participant Data Return Projectproject, with the aim of highlighting current industry practice and identifying gaps and challenges in implementation to speed industry uptake. As a first action, in summer 2025, we assessed the current state of data return throughout the industry by surveying PHUSE member companies. PHUSE received a total of 14 responses representing 14 companies worldwide.

The published blog summarises findings and next steps for this project team. If you are interested in getting involved please email workinggroups@phuse.global.

We’re pleased to announce that the Real World Evidence Working Group will be holding its second multi-day virtual event from 30 September to 1 September–1 October 2026.

 Stay tuned for more details and registration information coming soon!