TRIALL.IO — Clinical Research Is
Going Digital


With the advent of organic chemistry and our capacity to isolate, analyze, and systematically quantify the effects of chemically active substances in the body, civilization entered the age of modern medicine. Since then, the world has seen the advent of more advanced medical technology and techniques that have resulted in the eradication of formerly “unbeatable” contagious illnesses and increased global life expectancy and wellbeing to unparalleled levels. While these accomplishments are commendable, the COVID-19 pandemic shows that humanity will continue to face challenges from new or re-emerging medical catastrophes. Furthermore, finding a solution to a medical condition sometimes entails shifting from one unmet medical demand to another. For example, transforming diseases that were previously untreatable into chronic problems necessitates society developing novel treatment techniques.


The following sections provide a summary of the issues.


Clinical trials involve a wide range of specialist players, with many crossing organizational and geographic lines. A typical ‘Phase 3’ clinical study, for example, has around 50 research locations spread over more than 15 nations. Clinical trial stakeholders work in silos, each using its own software systems, data formats, processes, and organizational structures. Furthermore, many stakeholders are hesitant to exchange data and documents for fear of compromising security and privacy.


Although all-encompassing eClinical platforms exist, they are generally only available to a small number of major, rich pharmaceutical companies (“Big Pharma”) since they are prohibitively expensive, frequently run on outdated infrastructure, and provide limited choices for external interaction. Because about 65 percent of trials are conducted by academics, hospitals, and smaller industry partners with little resources, the great majority of clinical researchers are hindered by a lack of monitoring, resulting in considerable time and money being squandered.


All clinical trial stakeholders are expected to keep and retain “essential” records in accordance with GCP principles and applicable legislation. Monitors and regulatory agencies may audit and review these critical papers at any moment to ensure the legality of the study and the integrity of the clinical data gathered. GCP requires important papers to be gathered in a Trial Master File (TMF), today an electronic variation, the ‘eTMF’, to enable the accurate and effective administration of all of these filing obligations. The important records provided within the eTMF should allow regulatory authorities to reconstruct trial operations and critical choices taken, giving definitive proof that a medical product candidate is safe and effective and meets market introduction requirements.


The aforementioned concerns are the root cause of an increasing number of data integrity issues discovered during clinical trial inspections, as reported by authorities worldwide. Furthermore, falsified or hidden clinical research data remains a risk. Several marketed medicines have been recalled in recent years for lack of safety or efficacy, highlighting how insufficient record keeping can endanger trial patients and health care consumers.


Data integrity concerns need costly study reiteration. For example, while academia and smaller industries generally execute the early phases of clinical trials (Phase 1 and 2), Big Pharma’s assistance is required to complete the latter stages and bring a potential therapy to market.


Another key industrial problem is ensuring patient participation for the duration of a clinical study (which can range from several months to many years). With a drop-out rate of 30% on average, over 85 percent of all clinical studies fail to retain enough subjects, resulting in costly delays.


We are launching a set of tailored clinical trial software apps as a first demonstration of our blockchain-integrated ecosystem. We have worked extensively with the medical research sector to guarantee that each of these eClinical solutions addresses particular industry problem areas.

The underlying product concepts have been confirmed by industry specialists from the European Commission’s Horizon2020 initiative for outstanding research and innovation.

Our modular yet complementary eClinical solutions are all intended to increase data integrity, auditability, and job efficiency in current medical research procedures. These features respond to industry regulators throughout the world’s rising need for data security and traceability.

A multi-sided platform

The Triall Ecosystem is intended to meet the demands of all stakeholders engaged in clinical trials, and it includes a diverse network of interconnected network members. We’ve divided them into the following stakeholder categories:


All clinical trial stakeholders, including sponsor representatives, CRO staff (e.g., project managers, clinical research associates, monitors, and data managers), site staff (e.g., investigators, research nurses, and pharmacists), and other parties interested in using the Triall Ecosystem’s applications.


These are the people who take part in clinical trials as research subjects (either patients or healthy volunteers). They may be linked to the Triall Ecosystem via our patient-level eHealth applications, which aim to actively inform, recruit, engage, and empower this critical stakeholder group across clinical trial lifecycles.


Providers of software solutions for clinical trial operations and data management. They may utilize blockchain-enabled data logging and authentication features, as well as other microservices, by connecting to the Triall Ecosystem, and they can offer their solutions in our multi-sided digital marketplace.


Individuals and organizations that provide technical services to the ecosystem and its community. They create, run, and audit smart contracts, as well as specifications, apps, and APIs for systems and their users. Other stakeholders benefit from the added functionality provided by these smart contracts, APIs, and apps.


The Triall Foundation is a non-profit organization that is authorized by the Triall Community to administer the ecosystem. The foundation is a public service provider that operates on behalf of the community and is in charge of the Triall Ecosystem’s daily operations, management, development, and upkeep.


These are the companies or persons who supply the underlying infrastructure on which the Triall Ecosystem runs, such as node operators and (cloud) storage providers. For example, Factom’s independent Authority Node Operators* guarantee network integrity by validating data blocks and publishing to a blockchain ledger. They give the network strength, speed, and security by following a shared governance structure, being totally decentralized, and operating full nodes with rigorous hardware requirements.


The Triall Community is made up of all organizations and individuals who wish to help the Triall Ecosystem grow and evolve, for example, by participating in decision-making, panels, discussions, development, or outreach. Community members can be members of the aforementioned stakeholder groups, but any party or individual with a genuine interest in the ecosystem is welcome.

Triall Community Fund

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Note: A sponsored article written for a bounty reward

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