Recapitulation of TRIALL PROJECT AMA event held at AMA LOVERS CLUB.

Venue: https://t.me/amaloversclub
Date: Tuesday, 20th April, 2021
Time: 14:00 UTC

The TRIALL PROJECT team was represented by @Rxvdwaalwho judiciously shared with us detailed knowledge and information about TRIALL PROJECT.

1st Segment: INTRODUCTION

Q1: Can you please introduce yourself and your background, also introduce the team working on TRIALL?

ANS: Sure, my name is Raymond van der Waal and I’m co-founder and Head of Marketing at Triall, where I’m currently lead responsible for all of our marketing, communication, and business development activities. My background is in biomedical sciences and business management and I have previously built experience as a researcher, entrepreneur, and consultant

Triall brings together a group of clinical trial experts, enterprise IT specialists, and blockchain developers. Our founding team members have all worked together over the past 5-10 years in business and academia

Combined, our team has managed 100+ clinical trials and co-founded 20+ ventures in Life Sciences and B2B software. This experience has left us with deep roots in the clinical trial industry and strong ties to blockchain and IT standards groups (W3C, DIF, IEEE)

These connections allow us to rapidly pilot test new software features with medical researchers who are working in clinical trials on a daily basis. It also provides us with the insights and network to continue operating at the forefront of industry developments.

Q2: Can you introduce TRIALL, what critical problems does it solve that existing solutions are not solving and what’s the competitive advantage?

ANS: Triall develops blockchain-integrated software solutions that promote the reliability and efficiency of clinical trials

Clinical trials are research studies that are necessary to evaluate the safety and efficacy of new vaccines and medicines before these enter the market. I think that everyone around the world understands the importance of having safe and effective vaccines and medicines, especially in emergency situations such as now with COVID-19

As the world’s first organization to implement blockchain technology in a live and running clinical trial, we are a frontrunner in applying blockchain to address two essential industry-wide needs:
(1) promoting traceability and auditability of clinical trial operations, which have become increasingly complex and data-heavy; and
(2) enabling the safe and compliant transfer of clinical trial data between organizations and systems, thereby promoting interoperability and tackling data compartmentalization

Regarding (1), our first product Verial eTMF enables the user to create verifiable proof of the existence and integrity of their trial-related documents through the creation of blockchain-registered immutable audit trials. This feature set is unique in the market, and fully answers to calls for improved data traceability and auditability by authorities such as the US FDA and the EMA

Regarding (2), we will introduce a decentralized identity and access management (IAM) layer that enables secure connections between currently isolated clinical trial software systems and their users. By connecting to our ecosystem, 3rd-party systems can authenticate their data using our blockchain infrastructure. Moreover, they can exchange data with other systems and users in our ecosystem in a secure and efficient way. This is a much-needed, but currently non-existing 'ecosystem' approach

We’re positioned to become a major infrastructure player for the future digital clinical trials ecosystem. And by taking this ecosystem approach, we will effectively turn competitors into collaborators 🙂.

Q3: Can you briefly describe the top milestones you have achieved and your target milestones with timelines, also share your roadmap?

ANS: Yes! absolutely, so please allow me to list some of our milestones:

- Working commercial product: We developed and commercialized Verial eTMF; a clinical document management solution with blockchain proofs of data integrity and authenticity

- World's first implementation of blockchain in clinical trials: We demonstrated the world's first implementation of blockchain in a live and running clinical trial through the use of Verial eTMF.

- Seal of Excellence: Received a Seal of Excellence for the Verial eTMF concept from the European Commission’s Horizon2020 program for top research and innovation worthy of investment.

- Triall whitepaper: Released the Triall Whitepaper, which provides the blueprint for our plans and vision

- International value network: Built a global partner and advisor network

Our future plans and core vision is the development of the world's first blockchain-enabled digital ecosystem for clinical trials

Moreover, we strongly believe in the power of community. Therefore, we’re heavily investing in building a strong community of synergetic partners, advisors, investors, and stakeholders that bridges the healthcare and crypto domains.

Q4: Triall seems to have a unique purpose

I need to ask, as of now, do you think you have a competitor?

ANS: There are many clinical trial software solution providers. In fact, this is one of the key problems we are targeting: there's a plethora of software systems that do not interact and integrate well

Our blockchain infrastructure tackles these issues. Existing clinical trial software providers can connect to us, and thereby interact with other solutions. Also, we offer unique features for proof of data integrity and authenticity so that the reliability of clinical trials is optimized

In other words, we’re positioned as a gateway for safe and efficient digital clinical trial activities, offering existing systems and clinical trial professionals an easy entry into blockchain and its unique benefits.

Q5: Can you briefly describe your PARTNERSHIPS so far?

ANS: Sure, Triall is supported by an international network of partners that bridges the healthcare and blockchain domains

Partnerships that have been instrumental to our success so far include our technology partner Sphereon.com (with whom we have co-developed our first application Verial eTMF and blockchain microservices), and our clinical operations partner CR2O.nl (a clinical contract research organization that manages clinical trials on a daily basis, and with whom we can rapidly pilot test our software solutions)

Moreover, our partnership with leading blockchain development agency Applicature.com has been key to the design, preparation and execution of our token sale, which is now in full swing

Currently, we're in talks with many more strategic partners in the healthcare and blockchain domains, who will be gradually announced over the coming period. Our core focus is the sustainable growth of our ecosystem and its underlying token $TRL, and onboarding new partners is key to this objective!

Q6: Can you give an overview of your Tokenomics, and the UTILITY of the $TRL and $T-CRED Token?

ANS: Absolutely, our ecosystem will know a tow token system consisting of $TRL and T-CRED

TRL is our main utility token and enables P2P compensation, governance, and community engagement

T-CRED can only be created by converting TRL, is used to pay for Triall solutions and is designed with the clinical trial professional in mind

So to briefly sum up the utility of our two-token system:
- Means of payment for all Triall solutions: by converting TRL to T-CRED and paying software subscription
- P2P compensation of stakeholders in the ecosystem
- Engage and incentivize stakeholders for providing value to the ecosystem: development, bug hunting, best practices, etc.
- Governance: include stakeholders in setting the course of the ecosystem
- Memberships & community rewards: loyalty programs with rewards for end-users and community members.

2nd Segment: LIVE Questions

Q1: You indicate that your team has published more than 250 peer-reviewed articles on innovation in medical research, on their experience. Is there a source where we can verify this data? Also, is the experience in the medical field sufficient for the crypto space?

ANS: Our team combines academic experts from several medical disciplines.

These include globally recognized thought leaders that have published extensively on topics such as immunology, infectious diseases, vaccinology, microbiology, eHealth technologies, drug and vaccine development.

Full publication lists can be validated through PubMed, Google Scholar, etc. Just recently, research by our team was published in the renowned scientific journal Science (https://science.sciencemag.org/content/368/6492/719).

This truly shows the 'trans-disciplinary' nature of our team, since this research article integrates insights from infectious diseases, vaccine development, and blockchain technology.

Q2: In spite of the advancement in present day science and technology, drug development speed, costs and success rate have not improved over the years. What does Triall think is the problem hindering the growth of clinical trial industry and how do you think these problems could be addressed so that unmet medical needs could be met?

ANS: Great question! So I think the majority of issues relate to data fragmentation. The clinical trial industry has become increasingly fragmented over the past decades, with modern trials including more (electronic) medical data sources, collecting more data, and involving a multitude of often isolated software systems to handle data

It’s not surprising that clinical trial professionals widely indicate to suffer from a lack of oversight in their daily clinical trial operations. This translates into process delays, reiterations, longer development timelines and higher costs for new medical solutions. According to regulators and health authorities worldwide, this problem is also at the source of the growing number of data integrity issues reported during clinical trial inspections

At Triall, we’re using blockchain-enabled technologies such as decentralized identifiers (DIDs) and verifiable credentials (VCs) for improving interoperability in clinical trials. Our vision is leveraging DIDs and VCs to shape a decentralized identity and access management layer that revolutionizes data discovery and exchange, optimizing privacy, security, and operational efficiency.

Q3: Can you tell me more about trial first product and how it helped create more awareness about your platform?

ANS: In the past 4 years, we carefully designed, developed, tested, and commercialized our first product Verial eTMF. The application is now being used in multiple commercial clinical trial projects with real clients.

Verial eTMF really allowed us to show that blockchain can be implemented in clinical research to promote data integrity and auditability. It will be followed-up by several other products that we plan to develop and commercialize over the coming perio, including Triall CTMS, a clinical trial management system for planning and oversight that reads and integrates data from other connected eClinical solutions, and Atena PRM, a partnering and communication platform that will speed up clinical trial startup times. Lastly, in the future, we will also develop several patient-level applications that focus on patient engagement and recruitment.

Q4: The first thing an investors, users, partners look in a project is security. To further win our confidence in your project. We will like to know if your smart contract has been audited and the company that did the audit?

ANS: Being in the clinical trial industry, you deal with a lot of different stakeholders and regulations. Security is a primary concern of any software solution in this space. Having immutable data in the mix complicates that more

Luckily we have experienced people on board currently, that know that you should never put Personally Identifiable Information on a blockchain, but only the proofs of that data. We will be working with Decentralized Identifiers for identity purposes, where data is stored of chain, but the proofs of that data is stored on chain. This data is encrypted in some cases even on a p2p basis, so that nobody can access that data in case of a breach of an IT system.

On the technical side there is also risks involved in smart contracts. We can do a lot without smart contracts, but whenever we use smart contract technology we always ensure that these contracts are audited by an external third party

We will always comply with relevant regulations (ISO, HIPAA, GDPR, eIDAS, ETSI) to ensure our operational practices are in order.

Q5: First of all, your project is amazing. The first project I see based on medical research and clinical trials, quite innovative in the world of cryptocurrencies. My question is in fact about what we have been living in the last year with the global pandemic of Covid - 19, given that your mission is the acceleration of vaccines, how has this challenge been for you? Have they worked on any vaccines for this?

ANS: Thank you for the kind words! 🙂 By streamlining clinical trial operations we aim to accelerate the time to market of new vaccines and therapeutics, something that will be highly relevant, especially in future pandemic emergencies.

As to the effect of COVID-19 on our business: the lockdowns and restrictions have not hampered our team’s productivity too much, but you miss the social aspects of meeting face-to-face. To illustrate, we have been able to continue our product development as usual, as most of our product and development team’s touchpoints were already digital. Moreover, considering business development, discovery calls, and product demos can easily be done through video communication tools and, essentially, the entire sales cycle can be digitalized

Fun fact: Verial eTMF is now being used in a COVID-19 vaccine clinical trial ;)

Q6: In building the world’s first blockchain-enabled clinical trial ecosystem, what are the challenges that were encountered by the triall team? And to what extent have you tackled these challenges?

ANS: I believe we are presented with an incredible opportunity: we're a first-mover in our industry, and are positioned to become a key 'translational agent' for blockchain technology in clinical trials

We now have the means and the momentum to make a big positive impact. However, as a startup that develops a complex emerging technology, we also need to overcome considerable challenges (as you rightfully point out).

Luckily, we can draw on the extensive experience of our team, both in the clinical trials industry and in software development processes

To summarize some of the key challenges:

- Building trust & reputation: Quickly building trust, reputation, and track-record are of key importance for any new company entering the market, considering the sometimes billion-dollar costs of product development and the safety of research subjects involved. This is especially true when you are delivering new technologies that are not yet known to the target market. Triall’s team members have managed 100+ clinical trials and have carefully built their industry network over the past 20 years.

- Compliance: Compliance and 'inspection-readiness' are key pillars of sound and reliable clinical trial operations. While we implement radically innovate technologies, we never compromise on quality. Together with our quality & compliance advisors we ensure that Triall solutions follow (industry-specific) international quality standards and regulations.

- Certification & security: Triall builds on proven and certified technology, such as the Alfresco platform, AWS cloud services, and open blockchain standards (W3C,DIF). Moreover, we leverage the strength and security of existing blockchain infrastructures, providing us with network strength and security right from the start and allowing us to fully focus on the development clinical trial software solutions.

CONCLUSION:

I enjoyed engaging with all of you and want to thank you for your high-quality questions! 🙏🏽

For those interested in our pre-sale. Please register on our website (triall.io)

Thanks again for having me. It was a pleasure answering all of your questions.

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