Triall Whitepaper: A digital ecosystem for clinical trials

R.X. van der Waal, J. Flach, M.B. van der Waal

Research output: Online publication or Non-textual formOnline publication or WebsiteProfessional

86 Downloads (Pure)

Abstract

The clinical research industry is responsible for the delivery of novel medical solutions to society by systematically evaluating their safety and efficacy in clinical trials. A steady and efficient influx of these medical innovations is critical for meeting society’s current and future medical needs. Unfortunately, the industry faces several persistent issues that make clinical trial operations overly complex, lengthy and resource-inefficient.

Most importantly, due to trials involving many different organizations, locations, and software systems, virtually all 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.

Triall commits to addressing these issues and enabling a future of smarter, safer, and more-efficient clinical trials. Bringing together a consortium of clinical operations experts, blockchain developers, and smart document processing specialists, we are building towards the world’s first, fully integrated online environment for clinical trials that is inclusive to all clinical research professionals—regardless of budget, function, or organizational type. It offers a series of modular Software as a Service (SaaS) solutions that directly tailor to identified needs of clinical researchers, utilizing the strengths of blockchain technology and artificial intelligence (AI) where these truly add value. Moreover, it offers a place where novel clinical IT initiatives originating from the clinical trial community are supported and facilitated to thrive, making the online environment function as a true ecosystem: the Triall ecosystem.

The ecosystem’s infrastructure enables verifiable proof of the authenticity and integrity of clinical data, establishing an immutable audit trail of documents and their evolution over the course of a trial. This functionality fully answers to increasing calls for meticulous documentation as decreed by regulators, and promises to improve the quality and efficiency of clinical research throughout the pharmaceutical value chain. In addition, the infrastructure allows for consolidating the now severely fragmented landscape of clinical software applications into a multi-sided platform. Applying a microservices architecture of blockchain APIs, previously isolated applications are enabled to connect to our blockchain infrastructure and use its functionalities. Moreover, using the blockchain for cryptographic data access control and service discovery, Triall facilitates secure communication of key metrics, and connected solutions may start to act in concert. Ultimately, this promises to streamline clinical operations of research professionals that are often forced to use several function-specific applications side by side.

The ecosystem operates on the Factom® Protocol, an open source data integrity protocol that is optimized for enterprise adoption and has a track-record of industrial and governmental application. The non-profit Triall Foundation is the ecosystem’s governing body and public service provider, responsible for the development, management and maintenance of the ecosystem and its functionalities. The foundation sees to it that any future excess income is re-invested in the clinical community through incubator and charity schemes. Ultimately, Triall’s approach, architecture and governance model are fully geared to advance clinical development towards meeting unmet medical needs.
Original languageEnglish
PublisherTriall Foundation
Media of outputOnline
Publication statusPublished - 23 Dec 2019
Externally publishedYes

Keywords

  • blockchain
  • clinical trials
  • digital ecosystems
  • data management
  • data integrity

Fingerprint Dive into the research topics of 'Triall Whitepaper: A digital ecosystem for clinical trials'. Together they form a unique fingerprint.

Cite this