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Triall Insights

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. The Triall ecosystem promotes trust, research data integrity, and auditability throughout all phases of clinical development, utilizing 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 undertaking.

Addressing persisting barriers to efficient medical innovation

Clinical trials: a complex and lengthy undertaking

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

The many different clinical trial stakeholders operate in relative isolation, each applying their own systems, data formats, workflows, and organizational structures. 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 and costly reiterations of research activities.

Reduced trust & impaired reputation

Whereas the industry was once held in high regard for its pivotal role in the advancement of human health, cases of error or misconduct have reduced trust in the clinical trial industry among consumers and regulators as several marketed drugs have been recalled for lacking safety or efficacy. As a result, clinical researchers experience problems with recruiting patients for their clinical trials, and resources are wasted on promotional practices. Furthermore, these issues have led to even more stringent regulatory requirements, adding to the burden of documentation for clinical research professionals.

Low patient engagement

Safeguarding patient engagement throughout the full length of a trial (ranging from several months to multiple years) is considered another major challenge. With an average drop-out rate of 30%, around 85% of clinical trials fail to retain enough patients. This often results in costly delays. Moreover, issues around patient retention can have a profound impact on the outcome of a clinical trial and thereby add to the already significant risks in today’s clinical development.

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 5 core pillars

1.

Research data integrity

Assuring reliable, authentic, and auditable research data throughout clinical development by leveraging the strengths of blockchain technology, thereby rebuilding industry trust and reputation.

2.

Oversight & Advanced decision-making

Providing a secure online environment that integrates different eClinical solutions, thereby consolidating the unconnected, providing oversight, and enabling advanced decision-making.

3.

Patient engagement

Innovating the means to communicate and interact with subjects enrolled in clinical trials, thereby enhancing their engagement and retention.

4.

Optimized partner selection

Facilitating, harmonizing and logging interactions between outsourcers and vendors, thereby making clinical trial partnering inclusive,  simplified and auditable.

5.

Meeting unmet needs

Facilitating and supporting initiatives that accelerate clinical development, thereby meeting current and future unmet needs.

Triall ecosystem features

4 highlighted apps

Data & Document Verifier

Blockchain-enabled
eTMF solution

Expected Beta release:
Q2 2019

Integrated Trial Management Dashboard

Consolidating third-party and in-house eClinical solutions

Pending

Partner Selection & Management platform

Blockchain-enabled clinical trial partnering solution

Pending

Incubator Program

eHealth and eClinical innovation

First 2 projects enrolled

The token system

Digital currency to fuel the ecosystem ...

The Triall ecosystem represents a micro-economy that is fuelled by its own digital currency, the TRL token. This network token is used for operating and using the ecosystem and its functionalities, and serves the following purposes:

  • Provide access to premium ecosystem features
  • Direct Peer-to-Peer (P2P) compensation to those who build and offer applications within the ecosystem
  • Grant voting rights in the governing Triall Foundation, proportional to one's stake
  • Promoted listing on Triall's partnering platform
  • Reward users for adding content and insights
  • Pay smart contract developers and auditors for their services

... while remaining open to regular currencies

In order to ease adoption for the end-user, the ecosystem offers the possibility for Triall application users to pay in fiat currency. The Triall Foundation or a 3rd party vendor may pay for transactions with TRL on behalf of those that prefer the familiarity of their own paying models. As users are thus not required to directly deal with tokens, this effectively removes a major barrier to adoption for both end-users and industry (e.g. eClinical solution providers).

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

PhD candidate, holding degrees in Biomedical Sciences and Entrepreneurship. Has been designing real-life use cases for blockchain technology in clinical operations and data management over the past years.

Mark van der Waal

Director of Research & 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

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.

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 Leiden University Medical Center (LUMC). Founder and Director of the National eHealth Living Lab (NeLL). Authored 190+ peer-reviewed papers on eHealth, mHealth, and disease management. Raised €30M+ in funding over the past 15 years.

Prof. Sjaak Bloem, PhD

Nyenrode | Janssen
Advisor Innovation

Professor (Health care consumers & Experienced health) at the Center for Supply Chain Management and Marketing, Nyenrode Business University. International expert in health consumer behavior, methodology and health care innovation. Working for Janssen (pharmaceutical co. 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.

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 CRO’s.

Official partners

Development roadmap

1

2016–2017

Research & Ideation
2

2018

Development of MVP & Partnering
3

H1 2019

MVP release candidate & Pilot
4

H2 2019

Expansion of value network & ITO
5

H1 2020

Building & Onboarding
6

H2 2020

Integration & Expansion
7

H1 2021

Clinical Trial Ecosystem
8

H2 2021

Platform growth
9

2022-beyond

Next-generation Clinical Trials

Research & Ideation

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

Development of MVP & Partnering

  • Translating drafts into real-world clinical trial use cases
  • Triall's managing partner incorporated as a Dutch business entity (B.V.)
  • First strategic partnerships established
  • Development of the MVP (eTMF solution) initiated
  • Launch of the Triall website (triall.io)

MVP release candidate & Pilot

  • Triall Foundation established
  • Release candidate version of Verial eTMF
  • First clinical trial on the blockchain, demonstrating the utility of Verial eTMF
  • Release of the Triall whitepaper

Expansion of value network & ITO

  • Expansion of value network of advisors and partners
  • Release of the Verial eTMF solution (v1.0)
  • Initial Token Offering

Building & Onboarding

  • Development of follow-on applications and APIs initiated
  • Onboarding of first eClinical solution providers

Integration & Expansion

  • Release of Verial eTMF (2.0)
  • Release of the Verial API series
  • Integration of first eClinical solution providers to Triall's microservices infrastructure
  • Release of Trialwiki

Clinical Trial Ecosystem

  • Release candidate version of Triall CTMS
  • Release of the Triall API series
  • Expanding network of connected eClinical solution providers

Platform growth

  • Release of the Atena Partnering Directory and Communication Platform
  • Expanding network of connected eClinical solution providers

Next-generation Clinical Trials

  • Release candidate version of the Patient Recruitment & Retention application
  • Release candidate version of the Treatment Adherence application
  • Development of other follow-on (community-driven) ecosystem applications and features

Please note that the provided roadmap 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
  • Version1.0
  • Date of release17 April 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

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