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Emerging Trends & Innovation |
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The Cloud Adoption in the Life Sciences Industry 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 providesguidance 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. |
Data Transparency |
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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 Patient Data Return Project, 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 |
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Nonclinical Advance Event – Save the Date |
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The Nonclinical Topics Working Group is excited to announce a multi-day virtual event coming 10–12 February 2026. More details coming soon! |
RWD Real World Data Autumn Event – Save the Date |
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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 October 2026. Stay tuned for more details and registration information coming soon! |
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The Value of Plain Language Summaries (PLSs) project team within the Data Transparency Working Group, is calling for volunteers! This project has been initiated because whilst the industry has put significant efforts into developing and disseminating plain language summaries of trial results (PLSs) to promote transparency and engagement, there remains a gap in quantitative evidence of how these documents are used and what value they bring to the trial participants and the general public. Gathering feedback from trial participants – the primary audience for PLSs – and other readers will provide meaningful insights into their value and inform improvements. The team will be creating a survey to evaluate the value of PLSs and the survey feedback will be shared as a white paper authored by the group. If you’d like to become a valued project member, please get in touch with workinggroups@phuse.global by 19 January 2026 ahead of the kick off meeting scheduled for Tuesday 20 January 08:00 EST / 13:00 GMT / 14:00 CESTCET |
If you would like to get involved in a PHUSE Working Group Project, please explore the projects via the Volunteer Board and contact the PHUSE Office on workinggroups@phuse.global to express your interest. |
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