Clinical trials of drugs and treatments are time-consuming and expensive. Even before the trials can begin, various protocols, research ethics, methods, and types of participations (voluntary or by proxy) are examined to safeguard the safety of those taking part.
When subjects are selected to participate, there then follow physical examinations, examinations of medical histories and the subsequent signing of consent forms.
Multiple layers of scientific criteria and testing scrutiny are applied during the trial period to determine best practices for administrating the drug and ensuring any possible side-effects for the patient are minimised.
All of these areas of connected research can be problematic and a missed step at any stage can prove to be costly. Previous independent research has shown that around 80% of clinical trials fail to meet enrolment timelines and any delay results in substantial loss of revenue for the pharmaceutical company.
More recent independent studies have suggested that blockchain technology and a decentralised structure can provide a remedy for the management headaches associated with conducting clinical trials.
ClinTex is looking to resolve the inefficiencies present within the clinical trial phase in an attempt to eradicate the delays and spiralling costs of bringing a new medicine to market.
The project team believe that a major issue for clinical trials is that they are traditionally reactive rather than proactive. That is to say, problems are only identified after they occur and, even if the problems are acted upon, they often result in incomplete data gathering which is a major cause of clinical trial failure.
To combat this, ClinTex propose the use of machine learning to provide predictive data for all aspects of the procedure – from any related administration through all operational considerations and into the final clinical trial functions.
This will be a unique selling point for ClinTex and appears to have given them first mover advantage in this particular arena. Although there are some powerful players around this market, companies such as DeepMind, Alphabet’s AI division, seem to be centred on utilising data to “help clinicians predict, diagnose and prevent serious illnesses.”
By collecting data in normal healthcare settings with the aim of optimising patient treatment with existing medicines, DeepMind are operating in a different space compared to the clinical trials which ClinTex target, as they focus on developing new and more effective treatments for patients.
Likewise, existing, centralised providers such as Tibco are concerned with individual tasks in clinical trials rather than the end to end coverage that will be offered by ClinTex’s CTi platform.
Along with the whitepaper, technical paper and one-page guide, ClinTex have a most comprehensive FAQ section on their website that serves to answer most pressing questions of potential investors.
While the one-page guide is a brief introduction to the project, the whitepaper provides ample industry background including illustrations of the high costs experienced by pharmaceutical companies conducting clinical trials. A run down of the platform’s unique selling points to address these pain points with emphasis on the DApps (see below) is also included.
Despite touching upon the blockchain mechanism used on the platform, the whitepaper leaves the more intricate workings to be explained in the 23 page technical paper. Here, readers will find details of the integration of the decentralised components of the CTi platform including the CLX smart contracts and Storj file system as well as the overall security provision.
ClinTex’s analytics and data solutions are accessed through their Clinical Trials Intelligence (CTi) Platform which runs on the Ethereum blockchain.
Clients need to purchase the native platform utility token (CLX) in order to validate a yearly license. These tokens are then staked in the platform’s wallet for the duration of the license. The actual amount of tokens will also determine the levels of access and can be used as a means of payment within the ecosystem.
It is expected that the increasing client base will result in a consistently escalating amount of CLX being required for staking for access licences, continuing to reduce the circulating supply. Where a client allows a licence to expire without renewal, 25% of their staked tokens will be destroyed permanently before the rest are returned to the circulating supply.
By adopting this pay-per-use model, customers can avoid expensive hardware costs and will gain enhanced workflow management tools.
To facilitate larger Pharmaceutical clients, a subsidiary of ClinTex – ClinTex UK – will act as a brokerage service by taking payment through traditional gateways, which it will then use to purchase CLX from the circulating supply on public exchanges on clients’ behalf.
From a user standpoint, the blockchain element will provide a fully immutable audit-trail that is demanded by the medicine regulatory authorities.
Besides being a decentralised database of clinical data, the platform will host 7 separate DApps which will serve to bring efficiency throughout the various clinical trial stages.
Each serves a separate function and although each contain complex information indicators, for the sake of this review they can be seen in the following simplified terms.
- CTi-OEM Application: provides operational oversight of the clinical trial for management.
- CTi-CDV Application: enhanced visualisations that flags any patient risk with recording of any corrective action taken.
- CTi-PDA Application: predictive analytics tool that uses all available clinical data to forecast issues of concern.
- CTi-RBM Application: deploys a pharmaceutical company’s data resources in a predictive, rather than reactive, approach to ensure effective risk based monitoring.
- CTi-PRR Application: manages the recruitment and retention of patients involved in clinical trials and uses AI to predict when someone is at risk of withdrawing from the study.
- CTi-SIM Application: handles the recruitment of physicians to run clinical trials and the token payment compensation by the pharmaceutical company to them based on data-driven milestones and key performance indicators.
- CTi-VMM Application: vendor management tool that enables payment to any third parties involved in the trial using similar indicators as the CTi-SMM.
ClinTex have assembled a large team drawn from not just from the clinical and medical professions but also specialists in business development and blockchain architecture. With embedded LinkedIn profiles with established connections, the work and academic history of those involved point towards a company who have the major bases covered.
Neill Barron for example is the Director of Clinical Data Services and holds an MSc in Pharmaceutical Technology & Business and over 20 years clinical development experience in senior roles in clinical data management, data analytics, process improvement and clinical data monitoring.
Medical Officer Dr. Samandip Dhesi already manages a number of NHS funded initiatives and research projects. He will lead the partnership collaborations that will deploy the CTi platform in academic research settings and demonstrate the value of CTi in clinical trials.
Several advisors are on hand to guide the start up and these include two, Binod Nirvan (founder of MixERP) and Ihor Pidruchny (a partner at Applicature), who have extensive experience of working with blockchain technology.
In addition to their listed advisors, ClinTex have aligned with a number of strategic partners to grow their platform and integrate it into the wider cryptocurrency eco-system. These include well known industry names such as the Enterprise Ethereum Alliance and the Global Blockchain Consortium and more specialised health-related firms such as Intellimed who focus on streamlining the UK’s National Health Services (NHS) processes.
The exact date for launching ClinTex is still to be determined but it is expected to be in the final quarter of 2018.
The basic price for the CLX tokens will be 1 CLX for $0.10 with a 20% bonus available for purchasers during the pre-sale.
Over the course of the pre-sale and public sale, half of the total supply of 366,541,667 CLX tokens will be available and any unsold tokens will be burnt.
A hard cap of has been set at $17 million with a soft cap of $4 million has been announced. While the full amount would allow for the full implementation of the roadmap, the smaller amount would be used to develop three core DApps – CTi-OEM, CTi-CDV and CTi-PDA, which would lead to further revenue streams being created.
ETH, BTC and BNB (Binance Coin) will be acceptable as payment for both the private and public sales. Although still to be confirmed, fiat currency is also expected to be accepted – EUR, GBP, USD, CHF, RMB & KRW, payable by Visa or Mastercard.
The CLX tokens that are distributed to partners, advisors and management team will all have a six to twelve-month vesting period. The proportion of CLX tokens reserved for Pharmaceutical Industrial Trials & Testing will be locked until the full live net launch and will not be in public circulation.
KYC and AML procedures will apply and the whole sale will operate under the Malta Financial Services Authority (MFSA) Regulated ICO Framework (Virtual Financial Assets Bill).
2018 Q2 (Phase 0)
CTi Date Model Design
2018 Q2 – Q3
CTi-OEM Prototype Development
Strategic Partners Private Round
Pre-sale and Public sale
2019 Q1 (Phase 1)
CTi GUI Development (with integrated CLX wallet)
Blockchain verification of CTi Pre-processing data
2019 Q2 (Phase 2)
CTi-OEM and CTi-PDA Development
2019 Q3 – Q4
Migration on-chain of CTi Clinical Data Statistical Summaries
CTi-RBM and CTi-CDV Development
2020 Q1 (Phase 3)
2020 Q3 – Q4
Migration on-chain of the CTi Date Model and CTi Processing Engine
There is enough material to suggest that ClinTex is aiming to address a real need within the clinical trial field. Tokenomics for the project are straightforward with minimal bonuses applicable and a clear team vesting period. The acceptance of Binance coin in the ICO adds another level of interest and, although no partnership is stated or implied, investors may feel it increases the possibility of a future listing opportunity with the exchange.
Maybe most importantly, an able team is backed by experienced advisors and together they have shown the foresight to partner with useful allies within the blockchain arena and realm of medical services.
The downside column is much shorter but it should be noted that there is currently no working product and the roadmap suggests that some of the infrastructure will not be fully available until well into 2020 which could hamper uptake of the platform.
The whitepaper states that one of the reasons ClinTex ClinTex has partnered with Intellimed is that they will “…deploy the CTi platform in academic clinical research settings.”
This suggests that a firm footing for the initial launch of the platform has been established so it is the forward momentum of ClinTex, that includes expected on-boarding of other pharmaceutical companies in mid-2019, that contributors to the ICO will need to judge.
Given that they have first mover advantage in this particular specialised arena, the fundamentals appear to outweigh the minor concern and marks ClinTex as an ICO worthy of serious consideration.