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      • Anonymization of Imaging Data
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    Data Transparency

      Data Transparency

      Sept 25, 2025


      Working Group Scope

      Active since 2014 the Data Transparency Working Group is made up of more than 70 active members from pharmaceuticals, CRO’s, software and academia, as well as CDISC and data privacy experts.

      Team members have since collaborated on developing a data de-identification standard for SDTM (known as the ‘PHUSE de-identification standard’). Since then, the Working Group has expanded to address EMA Policy 0070 matters, create a Data Transparency Roadmap across jurisdictions, and has started to address aspects of GDPR that are relevant for the conduct of clinical trials. The Data Transparency Working Group also reviews, on a regular basis, draft deliverables, or guidance documents from regulatory bodies (e.g. the EMA, Health Canada), as well as other industry organisations such as TransCelerate, and academia (e.g, Cochrane).

      In addition to the projects PHUSE have continued to strengthen its place as the world’s largest home for data transparency events, by sharing vital knowledge of the field and creating a space where questions can be asked, and challenges addressed. The events look to meet the ongoing needs of data transparency within the clinical development arena and features thought-provoking presentations, panel discussions and Q&A sessions from experts in the data sharing field.

      Current Projects 

      Anonymization of Imaging Data

      Educate the General Population on Data Privacy and Data Sharing

      EU CTR Implementation

      Internal Clinical Study Data Sharing Process

      Patient Data Return

      PHUSE Stakeholder Review of UK MHRA Clinical Trials Regulation Guidance

      PHUSE Stakeholder Review of ISRCTN Results System Prototype

      Resources
      • Country-Specific Requirements for Clinical Trials Disclosure: Joint Effort by PHUSE and Xogene
      • PHUSE Community Forum: Data Privacy and Data Sharing in Clinical Trials –2023
      • Data Privacy and Data Sharing in Clinical Trials – Introduction
      • Data Privacy and Data Sharing in Clinical Trials – Importance of Clinical Trials
      • Data Privacy and Data Sharing in Clinical Trials – What Will I Receive and When Will I Receive It?
      • Data Transparency Winter and Summer Events
      • Data Transparency CSS Update – 2018
      • Data Transparency Working Group Update – CSS 2018
      • Data Transparency EU CSS Update – 2017

      Click here to search for all Data Transparency deliverables, past projects are housed under the archived section. 

      jean-marc.ferran@phuse.global

      Jean-Marc Ferran is an Independent Consultant based in Copenhagen with more than 15 years of experience in the Life Sciences industry. Prior to starting his company, Qualiance, he worked as a Statistician, Standards Manager and Director of Statistical Programming at Novo Nordisk and Ferring Pharmaceuticals. Jean-Marc has led the PHUSE Data Transparency Working Group since 2014 and is an appointed member of the EMA Technical Anomymisation Group and Health Canada Stakeholder Reference Group on Public Disclosure of Clinical Documents. Jean-Marc also chaired the PHUSE Annual Conference in 2012 in Budapest, was a Director on the PHUSE Board from 2014 - 2017, and is a Lifetime Honorary member of the society for his significant contribution to the organisation over a number of years.

      stephen.bamford@phuse.global

      Stephen is the Head of Clinical Data Standards & Transparency at the Janssen Pharmaceutical Companies of Johnson & Johnson. Stephen has been a member of the Johnson & Johnson team since 2016 and has helped to implement and support a number of data-sharing initiatives during this time. He has over 25 years of experience in the management of clinical trial and research data with pharmaceutical, life science and research organisations.

      In 2004, Stephen founded the PHUSE organisation. From inception, he has driven and continues to drive PHUSE, which now has over 10,000 global members. PHUSE runs over 25 well-attended events globally each year, including a data innovation symposium in partnership with the Food and Drug Administration.

      devaki.thavarajah@phuse.global

      Devaki has almost 10 years’ experience working with pharmaceutical, research and healthcare communities globally to help meet their clinical trial transparency and disclosure requirements. Devaki also identified and implemented process improvements for the UK government sector during the critical transitionary period of organisational change in the public health reform initiative. As part of the response to the global pandemic, Devaki contributed to the transparency project for one of the leading COVID-19 vaccines to receive approval, providing guidance to the marketing authorisation holder on the operational elements for EMA and Health Canada’s request for publication of the full clinical data used to support their authorisations of this vaccine.

      amcdonell@privacy-analytics.com

      As the Senior Program Manager for the Clinical Trial Transparency team at Privacy Analytics, Abby McDonell leads teams that leverage advanced AI-enabled technology to deliver anonymisation services for top 10 pharma customers.

      With a strong academic research background, Abby develops and implements solutions for clinical trial data sharing, applying risk-based data processing to maximise data utility while maintaining patient privacy. She employs advanced statistical methods and machine learning technologies to enhance anonymisation processes for structured data, images and documents.

      Abby previously co-led the PHUSE Good Transparency Practice Working Group project, where she helped define best practices for data transparency and create guidance to ensure anonymised data complies with legal requirements while preserving data utility.

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