PHUSE Data Transparency Working Group and Xogene have collaborated to build a platform to share and grow the industry’s knowledge of global and country-specific clinical trials transparency regulatory requirements. Currently, compliance information is siloed within the global and local regulatory bodies, making them difficult to interpret and track. The goal of this platform is to help you find and decipher transparency regulatory information by country quickly and easily. This platform aims to aid in maintaining compliance with the transparency requirements of the country where a clinical trial is being conducted.
This portal currently captures information on transparency requirements for more than 50 countries. The information on the country regulations is reviewed and updated for any changes on a weekly basis by the Xogene Regulatory Intelligence Team with endorsement from the PHUSE Data Transparency Working Group.
PHUSE is an independent, not-for-profit organisation run by a worldwide team of volunteers. We are a global community and platform for the discussion of topics encompassing the work of data managers, biostatisticians, statistical programmers, data scientists, and eClinical IT professionals. PHUSE has become the industry voice to regulatory agencies and standards organisations such as the FDA, EMA & CDISC.
More than 30 participants from pharmaceuticals, CROs, software, and academia, as well as CDISC and data privacy experts, have collaborated on developing a data de-identification standard for SDTM (known as the “PHUSE de-identification standard”). Since then the project has expanded to address EMA Policy 0070 matters, create a Data Transparency Roadmap across jurisdictions, and recently, 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 from regulatory bodies (e.g. the EMA, Health Canada), other industry organisations (e.g. TransCelerate) and academia (e.g. Cochrane).
To know more, please visit PHUSE Data Transparency.
Xogene is exclusively dedicated to clinical trial disclosure, transparency, data sharing, and innovative relevant technologies. Founded in 2010, Xogene brings deep regulatory knowledge as well as unparalleled experience with the global clinical trial registries to support clients in their quest to meet their trial disclosure obligations.
Our suite of light, agile online tools offer the most user-friendly and cost-effective path to managing trial transparency information and processes.
To know more, please visit www.xogene.com.