Triall’s first product ‘Verial eTMF’ is a blockchain-integrated clinical trial document management solution. Uniquely, Verial eTMF enables users to generate verifiable proof of the integrity and existance of their clinical trial data through blockchain timestamping. In summer 2019, a beta version of Verial eTMF was given green light for use in a real-world clinical trial (credited as the world’s first clinical trial on the blockchain). The first commercial version of Verial eTMF is now being onboarded and used in multiple clinical trial projects.
What’s an ‘eTMF’?
Document management is a common denominator throughout clinical research. Regulations require researchers to build a so-called 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 quality standards and regulations. Depending on the phase and size of the clinical trial, the eTMF can comprise thousands of documents. The eTMF plays a key role in providing regulators with conclusive evidence that a vaccine or therapeutic product candidate is safe and effective, and qualifies for market introduction.
Why did you build Verial eTMF?
The organization and management of the eTMF can be challenging, especially in multi-country clinical trials that involve a large number of hospitals. To illustrate, a recent industry-wide survey concluded that virtually all clinical researchers experience issues with keeping track of their documents and data in their clinical operations. Consequently, failures in document management are a persisting industry pain point, leading to significant trial delays, reiterations of research activities, and, ultimately, putting patients at risk. To make matters worse, these problems are also at the source of a growing number of data integrity issues being found during clinical trial inspections, as reported by the WHO.
Verial eTMF explained
Verial eTMF is an easy-to-use document management solution that assists researchers in effectively building and managing their eTMF (see figure below for a list of features). Put simply, Verial eTMF helps researchers to build their eTMF faster and more reliably, thereby reducing the timelines and overall costs of clinical trial management.
Uniquely, Verial eTMF allows users to create verifiable proofs of the integrity and existance of their trial-related documents using blockchain timestamping, thereby generating an immutable audit trail of clinical trial documents and data over the course of clinical development (which typically takes around 10 years for a new vaccine or therapeutic). This features promises to tackle the growing number of data integrity issues currently found during clinical trial inspections. It provides regulators with improvement insight into the authenticity and reliability of research data and thereby expedites the clinical trial and market authorisation process.
Verial eTMF in practice
Verial eTMF is currently being used in several commercial clinical trial projects and more projects are lined up to onboard this solution in their operations. To illustrate, Verial eTMF is currently being used in a clinical trial that evaluates a new treatment for Irritable Bowel Syndrome (IBS). Another project that is currently using this product is a clinical trial that studies a new treatment for autoimmune and chronic inflammatory diseases.
What’s next?
At Triall, we are always looking to improve Verial eTMF with other features that support researchers in decreasing manual workload and streamlining their clinical trial operations. Verial eTMF will be enhanced with a blockchain-registered digital signatures module (enabling the parallel signing of any file type) and an automatic document classification module that utilizes AI/Deep Learning to recognize and classify trial-related documents as soon as these are uploaded to Verial eTMF, enabling the automatic structuring, naming and storage of these documents in the right folder.
