Triall announces that its first software solution ‘Verial eTMF’ has successfully passed the pilot stage and is now being onboarded and used in multiple clinical trial consortia. In summer 2019, a beta version of Verial eTMF was given green light for use in a real-world clinical trial. This marked the start of a pilot aimed at optimizing the usability of the application while also strengthening Triall’s internal Quality Management System. Moreover, it enabled Triall to claim the ‘world’s first clinical trial on the blockchain’, making Triall the first organization to implement blockchain technology in a live and running clinical trial setting.
Last year’s pilot project proved to be instrumental in strengthening the usability of Verial eTMF. In collaboration with our development partner Sphereon, Triall’s product owner team has worked tirelessly on the usability testing and UI/UX design of Verial eTMF. In parallel, Triall’s Quality Management System has been extended to match current quality standards and international regulations related to clinical research, data security and data privacy.
Triall’s first software solution ‘Verial eTMF’ is a blockchain-enabled document management solution that supports clinical research professionals in building and managing a fully-compliant ‘electronic Trial Master File’ (eTMF): the compulsory collection of documents that allows for the reconstruction and inspection of clinical trial operations, and their compliance with international rules, regulations and quality guidelines. Uniquely, Verial eTMF enables researchers to create a blockchain-registered immutable audit trail of the content and evolution of their essential trial-related documents as soon as these are stored in the application’s cloud-based private repository.
This utility is powerful as it allows researchers to generate verifiable proof of the integrity and existence of their essential documents by demonstrating that these documents have not been altered after registration on the blockchain. It promises to drastically improve the reliability and auditability of clinical research throughout the pharmaceutical development chain, and fully answers to calls for meticulous documentation and data transparency by the U.S. Food & Drug Administration (FDA), European Medicine Agency (EMA), and other regulatory authorities. It also does not interfere with privacy laws (GDPR, HIPAA) as the documents themselves remain in Verial’s private repository while the blockchain only stores cryptographic references (hash codes) associated with these documents.
With the support of Dizer Capital (who joined the Triall initiative earlier this year) and our other partners, Triall is motivated and aligned to further extend the user base of Verial eTMF and continue the development of our software offerings over the coming time. While the current COVID-19 pandemic is a challenge to business and communities worldwide, it is likely to also create new avenues for supporting digitalization and cross-border collaboration in the Life Sciences. As an initiative aimed at making clinical research smarter, safer, and more-efficient, we truly hope to leave a positive impact on the current situation and are currently looking to get involved in a number of COVID-19 related projects.