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An inclusive online ecosystem for clinical trials

Triall commits to optimizing the medical innovation process by delivering an online environment that connects 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 trust and impaired reputation

The recall of several marketed drugs in recent years has led to decreased consumer trust and has fuelled skepticism around industry bias. Scandals regarding fraud and misconduct (e.g. fabricated or concealed research data) have further impaired the reputation of pharmaceutical companies in the eyes of consumers and regulatory agencies.

The damage to the industry has been substantial, resulting in costly settlements and promotional practices, problems in patient recruitment, and product withdrawals. Furthermore, compliance issues have led to more stringent regulatory requirements, further raising the total cost of clinical trials and thereby hampering the development of novel medical solutions.

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 professional and therefore exclusive 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. In a recent industry-wide survey, virtually all respondents acknowledged having issues with trial management processes, including study performance metrics and reporting, study and research site management and resource management.

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 and the quality of the trial’s data.

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.

Unmet medical needs

Regardless of today’s advancements in medicine, there are still many diseases that have no or only limited treatment options. Developing therapeutics to treat and cure these diseases is of major importance for global public health concerns and therefore is of increasing interest to international research funds and grant providers. Nevertheless, the current funding landscape for these ‘charity’ projects still remains scarce and innovators are challenged by tremendous competition to acquire such funds.

Our approach

An online environment that is inclusive to 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 the 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.

Delivering on 5 core pillars

1.

Trust & Reputation

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 and logs key metrics from eClinical solutions, thereby consolidating the unconnected, providing oversight, and enabling advanced decision-making.

3.

Optimized vendor selection

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

4.

Engaged patients

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

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

Released Q1 2019

Integrated Trial Management Dashboard

Consolidating third-party and in-house eClinical solutions

Expected Q4 2019

Vendor Selection & Management platform

Blockchain-enabled clinical trial partnering solution

Expected Q4 2019

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:

  • 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
  • Provide access to any premium ecosystem features
  • 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 project team

Executive Management Triall B.V.

Triall’s executive team 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

Chief Executive Officer

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.

Prof. Eric Claassen PhD

Chief Financial Officer

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

Niels Klomp

Chief Technology Officer

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.

Raymond van der Waal

VP of Marketing & Community Development

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

VP 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

VP of Clinical Affairs

PhD candidate and GCP-certified clinical researcher, operating at the interface of industry and academia to advance innovation in microbiota management. Early crypto and blockchain enthusiast, highly motivated to translate its benefits to end-user functionalities in the clinical domain.

Linda van de Burgwal PhD

VP of Operations

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

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.

Project Advisors

The project is strengthened by the support of several Key Opinion Leaders, clinical R&D specialists, and high-tech entrepreneurs. These Project Advisors and the organizations they represent contribute to the development of the Triall ecosystem through access to knowledge, expertise and infrastructure in their respective areas of expertise, ranging from eHealth and clinical software development, to patient engagement and clinical operations.

Prof. Niels Chavannes MD PhD

Leiden University Medical Center
National eHealth Living Lab (NeLL)

Full Professor of Primary Care Medicine, Strategic Chair of eHealth Applications in Disease Management. Founder of the National eHealth Living Lab (NeLL), scaling up eHealth initiatives using innovative approaches in public-private partnerships. Published over 190 peer-reviewed papers on eHealth, mHealth, and disease management. Raised over €30 million in funding over the past 15 years.

Prof. Sjaak Bloem PhD

Nyenrode Business University
Janssen (Johnson & Johnson)

Professor (chair: health care, experienced health) at the Center for Supply Chain Management and Marketing. International expert in health consumer behavior, methodology and health care innovation. Working for Janssen (pharmaceutical branch of Johnson & Johnson) from 2000 onwards in various innovation management positions.

Maarten Boender

Sphereon

IT entrepreneur since 1997, taking on management roles in the global software industry since 1983. Founded the Benelux operations of Magellan Software, now owned by OpenText, a key player in Java- and XML-based web content management and document processing. Co-founder of Sphereon, an API-driven platform-provider combining enterprise-grade microservices architecture with leading-edge AI and blockchain technologies. Invited speaker on blockchain for governmental bodies.

Official partners

Development roadmap

1

2016–2017

Research & Ideation
2

2018, H1

Concept development & Partnering
3

2018, H2

Website & MVP development
4

2019, Q1

MVP release candidate & Pilot
5

2019, Q2

Ecosystem beta, API development & ITO
6

2019, Q3

Onboarding & Upscaling
7

2019, Q4

Ecosystem release candidate
8

2020–onwards

Next generation clinical trial management

Research & Ideation

  • Academic groundwork on blockchain technology applied to medical innovation
  • Original concepts and ideas drafted
  • Core team established

Concept development & Partnering

  • Development of real-life use cases
  • Triall incorporated
  • First strategic partnerships established

Website & MVP development

  • Launch of the Triall website
  • Development of the MVP initiated

MVP release candidate & Pilot

  • Release candidate version of the MVP (eTMF solution)
  • Initiation of the first pilot clinical trial
  • Release of the Triall whitepaper
  • Development of additional eTMF features
  • Team expansion

Ecosystem beta, API development & ITO

  • Beta version of the Triall ecosystem
  • Development of APIs for third-party integration
  • Release of additional eTMF solution features
  • Initial public token offering

Onboarding & Upscaling

  • Onboarding and connecting eClinical solution providers
  • Upscaling use of the eTMF solution

Ecosystem release candidate

  • Release candidate version of the Triall ecosystem, including beta versions of the first Incubator Program applications (patient recruitment app, treatment adherence app)

Next generation clinical trial management

  • Expansion of the ecosystem with AI functionalities to enable advanced data analytics and risk-based trial management

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

The Triall whitepaper

We’re in the final stage of writing the Triall whitepaper, covering 40 pages of in-depth information on the Triall ecosystem:

  • Design and architecture
  • Team, advisors and partners
  • Applications and functionalities
  • Governance
  • Development strategy and roadmap
  • Contextual background
  • Token economics and ITO structuring
  • Version1.0
  • ExpectedQ1 2019

Contact information

Triall HQ

Bisonspoor 7000, Copenhagen Tower (6th floor), 3605 LT Maarssen, The Netherlands

E-MAIL (GENERAL)

contact@triall.io

Press & Media

press@triall.io

Chamber of Commerce (Amsterdam NL)

71656227

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