ClinTex
ClinTex
Token: CLX


Blockchain Powered Clinical Trial Management

PreICO dates
Start date: 2018-10-01
End date: 2018-11-09

ICO dates
Start date: 2018-12-03
End date: 2019-01-11

Registrated in: Malta

Platform: Ethereum
Type: ERC20

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ClinTex categories
Health Other
ClinTex whitepaper
Video
ClinTex token sale
KYC passing required Yes | Whitelist Yes | Restriction for countries USA
Soft cap 4,000,000 USD
Hard cap 19,000,000 USD
Token distribution in ICO
50%
50%
Acceppting BTC,ETH
ClinTex news, social
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Random whitepaper excerpts

Disclaimer
The ClinTex CTi whitepaper (the “Whitepaper”) serves as an introduction to our de-centralised clinical trials platform
(Clinical Trials Intelligence Tool – CTi) which is designed to address the key challenges for pharmaceutical companies
in initiating and conducting clinical trials to deliver novel, effective and safe medicines to patients. This whitepaper
has been created for informative purposes only and does not represent any offer or solicitation to sell financial
instruments or unites of any collective investment schemes and any such potential offeror solicitation of financial
instruments may only be made by ClinTex by means of a prospectus or other offering documentation in terms of any
applicable Maltese law. Parties and/or contributors are advised to read this document carefully in full, and exercise
due diligence, as information within this document may evolve to reflect ongoing development of the tools and
processes, outputs and lessons learned from pilot projects, feedback from clients, and ...

Contents
Abstract
Clinical Trials – The Current Landscape
Clinical Trials – The Current Landscape
Target Market
Competitive Analysis
The Opportunity for the ClinTex CTi Platform
The ClinTex CTi Approach
The Basics of Blockchain
Why a Blockchain Solution for Clinical Trials?
Documented Calls for the Application of Blockchain & AI to Healthcare and Clinical Trials
Introducing the ClinTex CTi Platform
Unique Selling Points
Clinical Trial Datahub
Decentralised Applications
Operational Efficiency Application (CTi-OEM)
Clinical Data Visualisation Application (CTi-CDV)
Predictive Data Analytics Application (CTi-PDA)
Risk Based Monitoring Application (CTi-RBM)
Patient Recruitment & Retention Application (CTi-PRR)
Site Investigator Application (CTi-SIM)
Vendor Management Application (CTi-VMM)
The Future of CTi
Real World Application of the ClinTex CTi Tool
Example 1: The CTi-OEM Study Performance Dashboard

Abstract
ClinTex is a clinical trials collaboration and data analytics platform that leverages the benefits of distributed ledger
technology (blockchain). It uses smart contracts on the Ethereum public blockchain to provide an end to end
decentralised solution that incorporates tools to drive collaboration in the sharing of clinical trial data across the
industry and significant quality and operational improvements in running clinical trials through advanced clinical data
review, insightful operational key performance indicators (KPIs), predictive data analytics and machine learning (AI).
The ClinTex Clinical Trials Intelligence Platform (ClinTex CTi) will vastly improve pharmaceutical companies’
operational and clinical effectiveness in setting-up, conducting, overseeing, reviewing, and meeting regulatory
standards for clinical trials.
The foundation of the ClinTex CTi platform lies simultaneously in the creation of an ecosystem that enables
interoperability of all clinical trial data views and, by using bloc...

Market Overview
Clinical Trials – The Current Landscape
Pharmaceutical and Biotech Companies conduct clinical trials to demonstrate safety and efficacy of new and promising
treatments with the objective of gaining regulatory approval from the Food and Drug Administration (US), the
European Medicines Agency (EU) and other relevant regulatory authorities in various geographical regions.
Phase I
clinical trials assess the safety of a drug in the initial phase of testing, which can take several months to
complete, and usually includes a small number of healthy volunteers (20 to 100), who are generally paid for
participating in the study. The study is designed to determine the effects of the drug or device on humans including
how it is absorbed, metabolized, and excreted. This phase also investigates the side effects that occur as dosage
levels are increased. About 70% of experimental drugs pass this phase of testing.
Phase II
clinical trials test the efficacy of a drug or device, can last from seve...

Respiratory System
Pain and Anesthesia
Oncology
Ophthalmology
Hematology
Cardiovascular
Endocrine
Gastrointestinal
Immunomodulation
Anti-Infective
Central Nervous System
Dermatology
Genitourinary System
0
20
40
60
80
100
120
140
Phase 1 Phase 2 Phase 3 FDA NDA/ BLA Review Phase Phase 4
Figure 1: Analysis of Clinical Trial Costs (in Millions) (Wong et al., 2014)
Target Market
The ClinTex CTi platform will enable more efficient clinical trials and is primarily targeted at the clinical trials
industry currently worth $350 billion. The clinical trial industry includes pharmaceutical companies, clinical research
organisations (CROs) and academic institutions conducting trials to test the safety and efficacy of new medicines.
Through these various sources of clinical trial data, the CTi platform will access and maintain sources of clinical trial
information such as medical data, patient data, v...

Competitive Analysis
At the time of writing there is currently is no direct competition from companies focussing specifically on the
application of blockchain and AI to the whole clinical trial process. Furthermore, ClinTex offers a breadth of product
features that will find application at all stages and in all key activities related to the development of new medicines
using clinical trials.
While there are numerous healthcare-related blockchain projects with seemingly overlapping features, the ClinTex CTi
platform is the only one that has been designed by clinical trial professionals to address a real and current unmet need
in the pharmaceutical industry that combines blockchain technology with advanced clinical data analytics to deliver
more efficient medicines development.
For example, IBM Watson Health and the FDA are developing an initiative that will define how blockchain can be used
to exchange healthcare data from varied sources, including electronic health records (EHR), genomic data, and health
...

The Opportunity for the ClinTex CTi Platform
With the annual number of registered clinical trials increasing from 3,294 in 2004 to 23,384 in 2013 (Viergever and Li,
2015), and the average cost of a clinical trial across all phases running at about $15 million, delivering even small
efficiencies in data handling during clinical trials has the potential to save billions.
Furthermore, during the last 20 years, the average number of trials per New Drug Application has increased from 30 to
more than 70, and the number of patients required in a typical submission has also increased from 1576 to more than
4200 (Parexel International Corporation, 2005). This continued evolution of the clinical trial landscape represents
significant opportunity for pharmaceutical companies to benefit from the unique ClinTex CTi platform which will help
them to curb and control spiralling costs with a “data-driven” and “risk-based” approach to running their trials.
For example, a 1% average cost reduction across all trials running today ...

The Basics of Blockchain
At its core, blockchain is a distributed system of recording and
storing transaction records. More specifically, blockchain is a shared,
immutable record of peer-to-peer transactions built from linked
transaction ‘blocks’ that are stored in a digital ledger. It is
considered immutable because any change to a record (previously
recorded block) must be agreed upon by a consensus of validators. In
other words, information that has been recorded can only be
changed if everyone agrees. Blockchain relies on established
cryptographic techniques to allow each participant in the network to
interact (e.g. store, exchange, and view information), without the
need for a third party. In a blockchain system, there is no central
authority; instead, transaction records are stored and distributed
across all network participants. Interactions require verification by
the network before information is added, enabling collaboration
between network participants whilst rec...