As 2019 comes to an end, the holiday season provides us with time to reflect on what has happened in the past year. It has been an exciting year for Triall, in which we initiated use of our first application, published our whitepaper, and expanded our global value network of partners and advisors. In this article, we look back at the highlights of our past year while also looking forward into 2020. We want to give a special thanks to all who contributed to our initiative and we’re excited to continue on our path towards a future of smarter, safer and more-efficient clinical trials.
Verial eTMF: the first blockchain-enabled application for clinical trials
February: Support from the Factom community to make Verial eTMF pilot ready
At the start of 2019, we received support from the Factom Protocol community in the form of FCT donations by a number of core community members. These members expressed their excitement about the potential contributions of Triall to the Factom ecosystem in terms of future partnerships, usage, and exposure. This gesture truly shows the power of a community and how we together can progress Triall and the Factom Protocol into the future. We are very grateful for the support we’ve received from these individuals. These funds enabled us to bring our first application, a blockchain-enabled document management solution named Verial eTMF, to pilot-readiness.
June: Factom Grant for the implementation of Decentralized Identifiers (DIDs)
We received funding as part of the second Factom Grant round of 2019. We are using these funds to develop a Factom-enabled Decentralized Identifier (DID) functionality within the Verial eTMF application. DIDs form the basis for the future of digital identity and access management. They can be assigned to any type of entity (e.g. a person, document, device) and can be used in activities such as the signing of documents, web authentication and access control.
July: The world’s first clinical trial on the blockchain, piloting Verial eTMF
One of the most significant milestones for us this year was initiating the use of Verial eTMF in a clinical trial. To the best of our knowledge, this represents the world’s first implementation of blockchain technology in a real-world clinical trial setting. Following positive assessment of its compliance with international quality guidelines and regulations, we initiated use of Verial eTMF in the clinical trial (phase II, ~50 participants) of one of our partners. We are currently working on optimizing the usability of the application while also strengthening our internal quality management system. We expect to release the first commercially viable ‘1.0’ version of Verial eTMF in the first quarter of 2020.
Sharing our vision for the clinical trial industry
March: Seal of Excellence from the European Commission
Earlier this year, we received a Seal of Excellence from the European Commission (EC). This seal was awarded for a project proposal we submitted in the context of the ‘SME Instrument‘ call in February. Through this subsidy instrument, the EC supports highly innovative European SMEs with breakthrough potential that are able to create new markets or revolutionize existing ones. Following evaluation by an international panel of independent industry experts, our proposal (which centered on Verial eTMF) was scored as a high-quality project proposal in a highly competitive evaluation process, and was officially recommended for funding.
April: Release of the Triall whitepaper
Another very important milestone for us was the official release of the Triall whitepaper (which you can download here). This document outlines our plans and vision for building towards the world’s first blockchain-enabled multisided clinical trial platform that is open to all clinical research professionals and aims to enable a future of smarter, safer, and more-efficient clinical trials. As a team, we were delighted to finally openly share what we had been working on for the past 2 years.
May: Presenting at the national ClinOpsDag
Triall presented at the national ClinOpsDag 2019 (‘Clinical Operations Day’) event, which is the largest annual event for clinical research professionals in the Netherlands. As part of the event, Joost Flach, our Head of Clinical Affairs, hosted an educational workshop on the possible implementations of blockchain technology in clinical trials. The workshop was very well received and stimulated a fruitful discussion on how this technology can be applied to improve day-to-day operations by clinical research professionals ‘on the ground’.
August: Triall represented at ARCS Australia
Triall advocate and advisor Allan Bukuya represented Triall at the annual ARCS Australia Conference in Sydney. The ARCS conference is the largest conference on clinical research, regulation, reimbursement and utilization of medical products in the Australian region, focusing on the latest trends and developments in the industry.
October: Clinical Research News featured interview with Hadil, Niels and Joost
In an interview with Clinical Research News, Hadil, Joost and Niels explain how we plan to function as a gateway for data integrity, auditability and system integration in clinical trials, leveraging the blockchain infrastructure of the Factom Protocol.
Growing our global network of advisors
We have been fortunate enough to have a number of people with various backgrounds join our initiative this year. These advisors bring a tremendous amount of experience in clinical research, have a deep understanding of the key challenges faced by the industry and are passionate about challenging and improving on the status quo. They will support Triall in the design and evaluation of our product offerings, helping us to translate user demands into concrete product features. Moreover, they will support us in implementing data analytics capabilities and risk-based management principles in our core features and will help us in building our quality management system, covering process improvement, SOP development, computer system validation, training, and coaching. Lastly, they will act as a soundboard in the development of our organizational strategies, supporting us with value creation and value appropriation.
A technical deep dive on Medium
For those interested in a technical deep dive into clinical trials and the possible implementations of blockchain, we started posting Medium articles outlining our vision for the industry. In our first article, we explain what clinical trials exactly entail and why they are so important to our health systems. Next, we published a 3-part series on blockchain in clinical trials, in which we dive into the unique opportunities offered by blockchain technology in tackling some of the persisting issues in today’s clinical trials. The first article of the series, covers how blockchain can be used as a tool in promoting data integrity, traceability and auditability. In the second article, we address how blockchain can be used to enable a tamper-proof and regulatory compliant infrastructure for digital identity and access management. In the third article, we explain how smart contracts can be used to govern data exchange, automate key activities and improve compliance in clinical trials.
This year’s academic publications on blockchain in clinical trials
We are not the only ones who spot the potential for blockchain in clinical trials. Earlier this year, an article was published in Nature, in which researchers propose a blockchain-based system to make data collection in the clinical trial process immutable, traceable, and potentially more trustworthy. The study concludes that a blockchain-enabled system could indeed offer an improvement in clinical trial data management by bolstering trust in the clinical research process and the ease at which regulators can oversee clinical trials. Another interesting publication is an essay by Leeza Osipenko in the British Medical Journal, in which she argues that blockchain offers a technical solution to eradicate data manipulation and improve the transparency, security, quality, and efficiency of clinical trials. Lastly, a group of IBM researchers have published an article proposing a novel data management infrastructure based on blockchain, with includes, among others, private channels to preserve confidentiality, smart contracts to enforce compliance, and an auto-generated immutable audit trail. Glad to see the scientific community is aligned with our plans for transforming the industry.
Looking forward: our outlook on 2020
We look forward to what will probably be another exciting year for Triall. In 2020, we will work towards the official release of the 1.0 version of Verial eTMF, which will be commercially available to clinical research professionals in the first quarter of next year. Moreover, we plan on conducting our Initial Token Offering (ITO) to grow our community and help us raise the funds required to build out the ecosystem. We will also continue the development of Triall CTMS, a dashboard application that integrates and visualizes the data being recorded by all applications connected to the Triall platform. Needless to say, we will continue to share our vision for the clinical trial industry, involving more and more parties in our initiative as we truly believe this is a collaborative effort.
Wishing you all a happy holiday season,
The Triall team.