Powered by the Open-Source blockchain infrastructure of the Factom protocol
Powered by the Open-Source blockchain infrastructure of the Factom protocol

A digital ecosystem for clinical trials

Triall is building the world’s first blockchain-enabled clinical research ecosystem, serving and connecting all who are involved in carrying out clinical trials. Triall aims to promotes trust, research data integrity, auditability, and system interoperability, applying the strengths of blockchain technology where these truly add value.

Our aim is to tackle many of the persisting issues that make medical innovation an overly complex, lengthy, and resource-inefficient endeavor.

Addressing persistent barriers to efficient medical innovation

Clinical trials: a complex and lengthy endeavour

The clinical research industry is responsible for the delivery of novel medical solutions to society. To this end, its core purpose is the systematic evaluation of candidate medical solutions in clinical trials. It often takes 10-12 years of highly regulated clinical trials to bring a single medical solution to the patient.

Patients, Sites, CROs, Sponsors, and Regulators

Each clinical trial involves a number of specialty stakeholders spanning various organizations and societal domains. Throughout a trial, these stakeholders need to interact in a broad range of trial-related activities, ranging from study approval to site monitoring, regulatory filing and research dissemination.

Current issues

A steady and efficient influx of medical innovations is critical to ensure that society’s (re)emerging medical needs are effectively met. Unfortunately, the clinical research industry is characterized by a number of issues that make the innovation process overly complex, lengthy and resource-inefficient. Triall’s solutions are specifically designed to address these issues, and thereby enable a future of smarter, safer, and more-efficient clinical trials.

Lack of oversight and interoperability

Biopharma, academia, hospitals, and contract researcher organizations often operate in relative isolation, each applying their own systems, data formats, workflows, and organizational structures. These stakeholders are reluctant to share research data across institutional boundaries in fear of security and privacy breaches. As a result, data is often scattered across different databases, hampering oversight, accountability and auditability in clinical trials.

In the past decade, a plethora of clinical IT solutions have emerged that aim to smoothen clinical operations and data management. Ironically, the majority of these function-specific solutions are unable to communicate with each other. Fully-integrated platforms do exist, but are far too costly for most clinical research professionals and therefore exclusively for large corporations. As a consequence, many clinical trials lack oversight and significant time and resources are wasted just on staying informed on the trial’s progress.

Difficulty in record keeping

Clinical trial stakeholders are required to maintain and store trial-related ‘essential’ documents in compliance with quality standards and applicable regulations. To support the correct and effective management of these filing responsibilities, these documents are collected in an electronic Trial Master File, the ‘eTMF’. The essential documents contained within the eTMF should enable regulatory authorities to reconstruct trial activities and key decisions made, providing conclusive evidence that a medicinal product candidate is safe and effective, and qualifies for market introduction. The organization and maintenance of the eTMF can be difficult, especially in multi-country trials that involve a large number of research sites. Consequently, failure in adequate recordkeeping is a persisting industry pain point, leading to significant trial delays as well as costly reiterations of research activities. To illustrate, while academia and smaller industry typically perform the early stages of clinical development, Big Pharma’s involvement is essential for completing the later stages and bringing a candidate treatment to market. Taking over projects from smaller stakeholders, Big Pharma are typically seen to reiterate research activities as a result of documentation inadequacies in upstream trial phases. This results in an enormous amount of unnecessary costs and ultimately delays time to market as well as driving the commercial price of the medicinal product under investigation.

Impaired trust

Clinical research has become increasingly complex, globalized, and compartmentalized over the past decade. This has led to an industry-wide need for novel approaches to speed up and streamline communication and interactions between different stakeholders. This need is further fueled by cases of error and misconduct, which have reduced trust among clinical research professionals, patients and regulators, leading to even more stringent regulatory requirements that add to the complexity of clinical research.

Difficulty finding the right partner

The increased complexity and globalization of today’s clinical research stimulates sponsors to outsource a substantial part of their trial-related activities to specialized service providers: contract research organizations (CROs). Selecting the right CRO can make the difference between study success and failure. If any of the contracted CROs fails to be compliant, it can have a significant negative impact on the conduct of the clinical trial, the quality of the trial’s data and the safety of the patient.

Our approach

A multi-sided platform for all types of clinical research professionals

Triall envisions the world’s first online environment that is inclusive and accessible to all clinical research professionals, regardless of function, organizational type, or resource level. From the first-time PhD researcher to the seasoned investigator, from the pharmaceutical manager to the nurse practitioner, Triall aims to optimize and ease clinical trial operations for all.

Governed by a non-profit foundation

The online environment is governed by the non-profit Triall Foundation, which is responsible for the development, management and maintenance of the infrastructure and provided functionalities. The Foundation sees to it that any future excess income generated is re-invested in the clinical community through incubator and charity schemes.

Offering solutions that tailor to the specific needs of the clinical research community

While offering a selection of ready-made functionalities that address industry-wide needs, Triall represents an environment in which novel initiatives originating from the community are supported and facilitated to thrive. This makes Triall function as a true clinical trial ecosystem.

Operating on an established blockchain protocol

The ecosystem operates on the Factom Protocol, an open source data integrity protocol that is fully optimized for enterprise adoption and has a track-record of industrial and governmental applications. Factom provides Triall with network strength and security right from the start.

Delivering on 4 core pillars

1.

Data integrity & auditability

Assuring reliable, authentic, and auditable research data using blockchain-registered immutable audit trails.

2.

Digital collaboration

Streamlining and harmonizing digital interactions using Decentralized Identifiers, Verifiable Credentials and other open web standards.

3.

Interoperability

Providing the building blocks for integrating different clinical IT systems, thereby connecting the unconnected, promoting oversight, and informing decision-making.

4.

Accessibility

Delivering intuitive and purpose-built user experiences that make medical research more inclusive,  simplified and efficient.

Triall ecosystem initiatives

4 highlighted projects

The Triall ecosystem comprises projects across the entire clinical research domain. These projects share a common vision of making clinical trials smarter, safer and more-efficient by promoting research data integrity, auditability, system integration and operational efficiency. Triall positions itself as a translational agent, bridging blockchain and data management expertise with a profound understanding of clinical research and the needs and preferences of clinical research professionals. On one end, Triall is engaged in developing its own proprietary blockchain-enabled Software as a Service solutions such as Verial eTMF and Triall CTMS. On the other end, Triall engages in developing blockchain-enabled Platform as a Service components (APIs) for a number of public-private initiatives.

Verial eTMF

Blockchain-enabled
clinical trial document management
solution

Triall CTMS

Integrated clinical trial management system, consolidating in-house and 3rd-party eClinical solutions

Atena Platform

Blockchain-enabled partner selection and management platform

Other projects

eHealth and eClinical innovation

Please contact us for inquiries

Meet the people behind Triall

Board of Directors

The team behind Triall unites profound knowledge of the clinical research landscape with in-depth understanding of the promises offered by blockchain technology. Combined, it has managed over 400 phase I-IV clinical trials in over 30 countries and published over 250 peer-reviewed papers on pharmaceutical innovation, including articles in top-tier academic journals such as Nature and Science. The team has experienced the challenges of managing pharmaceutical companies through all different stages of growth and innovation, and can draw on a strong combination of academic, entrepreneurial, and industrial experience in the target market.

Hadil Es-Sbai

President | Executive Director

Experienced CEO in the pharmaceutical and clinical research domain, with extensive experience in managing international clinical trials (phase I-IV). Fully geared towards making innovative treatments accessible to those in need.

Niels Klomp

Director of Technology

Experienced blockchain developer and serial entrepreneur with over 15 years of experience in various CTO roles. Guide of the Factom Blockchain, responsible for its full decentralization.

Linda van de Burgwal, PhD

Treasurer | Director of Finance

Academic entrepreneur, project manager and consultant. Co-founder of two successful Life Sciences management consultancies. Holds a cum laude PhD in science commercialization.

Rob Posthumus

Secretary | General Counsel

Corporate lawyer and deal-maker with extensive experience as legal counsel in the pharmaceutical and health care industries. Headed the legal department of Erasmus University Medical Center.

Raymond van der Waal

Director of Marketing

Researcher, management consultant and copywriter with a background in Biomedical Sciences and Entrepreneurship. Passion for making complex technologies explainable and understandable to a broader audience.

Mark van der Waal

Director of Product Innovation

PhD candidate and consultant in medical innovation management with degrees in Biomedical Sciences (Health Technology Assessment) and Entrepreneurship. Passionate (self-taught) graphic designer with experience in commercial web- and UX design projects for over 12 years.

Joost Flach, PhD

Director of Clinical Affairs

Project manager and clinical research scientist, operating at the interface between industry and academia. Experienced in clinical operations, medical writing and microbiota R&D. Dedicated to translating the benefits of blockchain technology to end-user functionalities in the clinical trial domain.

Advisory Board

The project is strengthened by the support of key opinion leaders and specialists in clinical operations, pharmaceutical innovation, and IT development. These Advisors and the organizations they represent contribute to the development of Triall’s solutions by providing access to knowledge, expertise and infrastructures in their respective areas of expertise, ranging from eHealth and clinical software development, to patient engagement and clinical trial operations.

Yassin Mobarak

Dizer Capital
Advisor Technology

Technology entrepreneur and blockchain enthusiast. Founded Dizer Capital, a private equity firm focused on supporting early stage businesses in DLT/blockchain, clean energy, and financial inclusion.

Prof. Eric Claassen, PhD

VU Amsterdam
Co-founder & Advisor Strategy

Immunologist, Full Professor and sequential entrepreneur. Co-founded over 20 companies in the Life Sciences. Government and boardroom advisor on biomedical innovation and entrepreneurship.

Sina Djali

Janssen
Advisor Clinical Trial Data Analytics

Head of Integrated Clinical and Operational Analytics in Enabling Business and Information Solutions at Janssen, with extensive experience in designing and implementing data-driven systems for clinical trial monitoring.

Prof. Niels Chavannes, MD, PhD

LUMC | NeLL
Advisor Innovation

Full Professor of Primary Care Medicine and Strategic Chair of eHealth Applications in Disease Management at LUMC. Founder and Director of the National eHealth Living Lab (NeLL). Authored 190+ peer-reviewed papers on eHealth, mHealth, and disease management.

Moses Ma

FutureLab
Advisor Business Development

Managing partner of FutureLab. Co-developed the first specification for universal identity on the Internet, invented the concept of eMarkets, and helped to establish the foundational guidelines for the semantic Web.

Po Chi Wu, PhD

UC Berkeley | HKUST
Advisor Strategy

Advisor at UC Berkeley, adjunct professor in management at HKUST and partner at FutureLab. Highly successful international VC and entrepreneur with more than 30 years of experience in innovation and entrepreneurship.

Prof. Sjaak Bloem, PhD

Nyenrode | Janssen
Advisor Innovation

Professor (Health care consumers & Experienced health) at Nyenrode Business University. International expert in health consumer behavior, methodology and health care innovation. Working for Janssen (part of Johnson & Johnson) from 2000 onward as innovation manager.

Danielle Bradbury

Galera
Advisor Quality & Compliance

Head of Quality Assurance at Galera Therapeutics, with extensive knowledge of SOP management, GxP inspection readiness, computer system validation, and quality compliance.

Cari Jacobs-Blom

CR2O
Advisor Quality & Compliance

All-round clinical operations and quality management specialist, with 25+ years in pharmaceutical R&D and clinical trial quality management. Compliance expert in FDA, EMA, and ICH-GCP laws and regulations.

Nick van den Bulk

CR2O
Advisor Clinical Operations

Head clinical operations, with 10+ years in managing international clinical trials (phase I-IV) across therapeutic areas. Currently leading CEPI and Horizon2020 clinical trials.

Maarten Boender

Sphereon
Advisor Product Development

Software and IT entrepreneur, with 20+ years in document management solutions. Founder of Magellan Benelux (sold to OpenText) and co-founder of Sphereon, optimizing document processing with enterprise-grade microservices architectures, blockchain and AI. Invited speaker on blockchain-enabled document management solutions across the globe.

Allan Bukuya

TrialDocs
Advisor eClinical Solutions

Founder of TrialDocs, with over two decades of experience in the pharma, CRO and eClinical industries. Expert in simplifying workflows and procedures at site-level to improve cooperation between clinical research sites and industry stakeholders.

Rob Helmich

Herakles Life Sciences Group
Advisor Business Development

Director business development and recruitment, with 15+ years in clinical research within the pharmaceutical and contract research services industry. In 2010 he changed his career path to providing staffing solutions for Life Sciences companies and CROs.

Official partners

Our roadmap

1

2016–2017

Research & Ideation
2

2018-2019

Early Development
3

2020

Market introduction
4

2021

Expansion
5

2022-beyond

Multi-sided platform

Research & Ideation

  • Academic groundwork on blockchain technology applied to medical innovation
  • Drafting original concepts and ideas
  • Core project team established

Take-off

  • Triall operating company and Triall Foundation established
  • Release of the Triall whitepaper
  • Development of Verial eTMF initiated
  • Development of DID integration as part of the Factom community grant
  • Demonstrating Verial eTMF (beta) in a first real-world clinical trial

Early Development

  • Release of Verial eTMF (v1.0)
  • Onboarding clinical trial consortia and COVID-19 initiatives
  • Development and extension of blockchain-enabled API library
  • Development of Triall CTMS initiated

Market Introduction

  • Release of Triall CTMS (v1.0)
  • Development of second line of follow-on applications and features (e.g. Atena, Patient-level applications)

Build-out

  • Release of Atena (partnering directory and communication platform)
  • Build-out of the Triall hub (online multi-sided platform environment for all Triall-related products & services)

Please note that the provided roadmap, milestones and deliverables are indicative and may be subject to change.

The Triall whitepaper

We’re proud to present you the Triall whitepaper. It covers over 40 pages of detailed information on our vision and plans for a blockchain-enabled clinical trial ecosystem, including:

  • Design and architecture
  • Team, advisors and partners
  • Applications and functionalities
  • Governance
  • Development strategy and roadmap
  • Contextual background
  • Token economics and ITO structuring
  • Version1.1
  • Date of release20 December 2019

The release of our first whitepaper marks an important milestone in a journey that we initiated over two years ago. It summarizes the results of an exciting process of collaborative research, design, and development efforts between our team of clinical innovation specialists and consortium partners. We’re thrilled to now be able to share our vision and plans, and we look forward to joining forces with more stakeholders in the clinical research and blockchain communities over the months to come. Together we will be able to realize a truly inclusive ‘ecosystem’ for all clinical research professionals.

Contact information

Triall Foundation Office

Bisonspoor 3002 – C701 (Copenhagen Tower), 3605 LT Maarssen, The Netherlands

E-MAIL (GENERAL)

contact@triall.io

Press & Media

press@triall.io

Chamber of Commerce (Stichting Triall Foundation)

71656227

GDPR