Clinical Trial on a Public Blockchain
On behalf of the Triall Foundation, I am excited to announce the world’s first clinical trial in production on the Blockchain. A beta version of the foundation’s Verial software application was given green light for use in a real-world clinical trial and is now live in production, following positive assessment of its compliance with international regulations and quality standards for medical research. This marks an important milestone in a journey that we initiated over two years ago. Furthermore, to the best of our knowledge, this represents the first real-world implementation of Blockchain in a clinical trial. Below, I’ll briefly introduce Triall, the Verial application, and our plans for a Blockchain-enabled future of smarter, safer, and more-efficient medical research.
Niels Klomp is the CTO of Triall, CTO of Sphereon, and elected guide of the Factom Blockchain.
Triall Foundation: smarter, safer, more-efficient clinical trials
Triall brings together a consortium of clinical trial specialists and Blockchain engineers, and was founded to tackle some of the persisting issues that make clinical trial operations overly complex, lengthy, and resource-inefficient. (More info on clinical trials can be found in this Medium article.)
Most importantly, due to trials involving many different organizations, locations, and data sources, virtually all clinical researchers experience issues with keeping track of their documents and data. Yet, increasingly stringent regulations demand meticulous documentation of all clinical trial conducts, and all documents and their changes should be auditable at any time.
Lacking oversight hampers recordkeeping, resulting in costly reiterations, errors, and even safety risks for patients and consumers.
We believe that applying Blockchain technology in the collection and processing of clinical trial data will become the industry’s golden standard. Among other promising use cases (as outlined in the Triall whitepaper), Blockchain can provide the many stakeholders involved in a clinical trial with indisputable proof that data has been recorded at a set time under a verifiable condition.
To improve the auditability and operational efficiency of clinical trial operations, Triall together with technology partner Sphereon is developing a series of modular applications on top of the Blockchain infrastructure of the Factom Protocol.
Verial: a Blockchain-enabled document management solution for clinical researchers
Verial represents the first application in this series. The clinical document management solution enables users to establish verifiable proof of the integrity and authenticity of essential research documents, and to establish an immutable audit trail of their evolution over the course of a clinical trial.
These utilities are powerful, as it generates proof that these documents have not been altered after registration. Hence, it promises to drastically improve the reliability