Revolutionizing Clinical Trials with the IoT and Blockchain Technology
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CBDS Health is a health technology company focused on revolutionizing the clinical trials space through the deployment of information technologies including the internet of medical things (IoMT), big data analytics.
The company’s virtual clinical trials platform is a cost-effective solution for researchers and contract research organizations (CROs). CBDS Health is currently enhancing this platform by tapping into the IoMT and deploying it as a solution for cannabis clinical trials.
The IoMT is a connected system of medical devices and applications that collectively gather data that is then delivered to healthcare IT systems through online networks. A growing market in the healthcare industry, according to Allied Market Research, the IoMT is predicted to reach $136.8 billion globally by 2021.
The CBDS Health’s Clinical Trials Management (CMTS) platform, was developed by ORCATECH, which is an academic sister organization originated at the Oregon Health and Sciences University (OHSU). CBDS Health acquired the IP for the virtual clinical trials platform from OHSU. The customizable platform incorporates state-of-the-art monitoring sensors and wearable technology in the home to track patient data in real-time and real-world scenarios. This allows for modularly composed clinical trials that integrate technologies, using standardized tools to provide process and data integrity for medical and science research. The platform also allows for easy reproduction of past clinical trials.
To date, the platform has been used in over 60 studies with over 1,000 participants and has captured over 1 million hours of continuous home monitoring data. All this information has resulted in over 130 peer reviewed publications.
CBDS Health’s mandate is to offer this platform to the cannabis industry as a solution for cannabis researchers and clinical trials. The company has partnered with GrowBuddy—a cultivation management solution—in an investment and development agreement to integrate their platforms to deliver a complete solution for cannabis product research and clinical trials.
ORCATECH has been supported by multiple collaborators that include Pfizer, General Electric, Microsoft, Phillips, Intel, Vtech, Sony, Novartis and Lilly. With the support of these partners and a group of research collaborators led by OHSU, CBDS Health aims to target the clinical trials market associated with cannabis, Alzheimer’s, Parkinson’s, mild cognitive impairment and pain management.
CBDS Health is led by a management team with valuable experience in both the health science, IoMT and network development spaces. The management team is also significantly invested in the company as primary stakeholders.
- Deploying CMTS platform that makes use of IoMT and integrated technologies for clinical trials
- Enhancing the platform security, transparency, data accuracy and data sharing
- Partnering with GrowBuddy to integrate both platforms as a solution for cannabis clinical trials
- Platform delivery via cloud deployment to client entities like CROs for clinical trials
- Also targeting initial clinical trials in Alzheimer’s, Parkinson’s, mild cognitive impairment and pain management
- Potential solution for development of precision/personalized medicine
- Experienced team of health science and network development specialists
CBDS Health’s Clinical Trial Management System (CTMS)
Healthcare systems maintain significant amounts of patient information that needs to be collected, shared, analyzed and stored. With the development of digital tools and the internet, this information has transitioned from being managed manually and on paper, to being incorporated into digital systems. Following this trend, components of the IoMT—interconnected devices/sensors that can be used to passively or actively gather and analyze real-time data—have been deployed to play a role in patient monitoring. Similarly, the IoMT is also proving applicable to clinical trials as it provides real-time health and behavioral information of test subjects in real-world environments.
Contributing to a growing market, CBDS Health is deploying its cloud-based CTMS platform. The innovative platform helps to set up clinical trials modularly, splitting the process into hypothesis generation, study design, budget creation, enrollment and retention, study operations, data management and analytics, and publication creation.
Using interconnected devices to gather data
The CTMS platform uses state-of-the-art sensors, wearables, surveys and other tools to detect digital biomarkers—human physiological and behavioral measures—and collect and analyze real-time and historical patient data associated with cognition, physical function, behavior, genetics and others. As such, the company’s pervasive computing solution continually monitors multiple symptoms, tracks medication intake and uses self-report surveys to collect critical information, continually providing data from over 200 patient homes. This approach has already turned the clinical trial process on its head, reducing paperwork, increasing real-world and real-time tracking that can be done outside of a clinical setting, and making data analysis much more efficient.
mHealth: Mobile communications
Like the IoMT, the mHealth market is also on the rise. According to SNS Research, the market is accounts for approximately $23 billion and is expected to grow at a CAGR of over 35 percent over the next three years.
CBDS Health hosts a mobile communication platform that enables screen sharing, file sharing, video and voice calling, SMS, chat and more. These interactions are powered by a global platform that serves approximately 40 billion interactions a year while maintaining HIPAA compliance and 99.95 percent service level agreements. All communications can all be stored and recorded for future review.
Identity and data security
One of the most pertinent issues facing clinical trials is the reproducibility of their data. Up to 70 percent of trials are not reproducible, and that is often linked to the fact that patient data cannot be validated , something that is solved by CBDS Health’s platform. On some occasions, the lack of reproducibility is a result of fraudulent data that has been fabricated or changed to help meet the goals of the trial. This brings additional costs—both monetary and reputational—to trial sponsors as they have to repeat certain aspects of the study and suffer from negative perceptions. Using better on-boarding and validation technologies combined with decentralization addresses this issue by improving the accuracy and the accountability of data collection through the implementation of permanent and auditable records that, for instance, include timestamps or other identifying indicators.
Healthcare is also at the top of the list when it comes to data breaches, with the UK Information Commissioner’s Office claiming that the health sector accounted for 43 percent of all data breach related incidents. As such, there is an opportunity to better enable software and hardware mechanisms that protect users and devices on the IoMT.
Cannabis Research and Clinical Trials
CBDS Health has partnered with GrowBuddy, a cultivation tracking application that currently hosts over 44,000 users. The integration of the two platforms will lead to a complete solution for cannabis cultivation, research and clinical trials with functionalities such as clinical trial planning and management, cultivation and product development, and IoMT data capture.
Clinical trials in cannabis space
Cannabis hosts hundreds of active ingredients divided into cannabinoids, terpenes and flavonoids, the benefits of which have been outlined by patients and caregivers in preclinical and observational studies. As the cannabis industry continues to grow its scientific reputation, it needs to further implement traditional product research and pharmaceutical practices as key components in the industry’s development.
Clinical trials for cannabis require an additional layer of tracking that covers the cultivation and acquisition of the target products. Any data associated to the growth and distribution of the product will help ensure the repeatability of the trial while maintaining the integrity of the process.
Cannabis companies that are leading the industry are those that focus on compliance, high-efficiency facilities that use process automation and tools like AI and IoT, as well as those that have strong R&D partnerships. Through their partnership, CBDS Health and GrowBuddy can help give companies a competitive advantage.
GrowBuddy cultivation management solution
GrowBuddy is collaborating with IBM Canada to collect data from growers, sensors and existing systems through its cultivation management application. This allows producers to visualize operations from seed-to-sale, giving them the opportunity to be proactive in their operations.
The platform allows cultivators to have a comprehensive view of operations and outstanding tasks at all times. It also allows for comparisons with past crops so as to help determine best-practice cultivation methods. This also leads to consistent quality that emerges from consistently tracked approaches for cultivation. Lastly, the platform also gives companies the ability to calculate production effectively.
The tool provides users with customizable dashboards, integration with multiple IoT devices and greenhouse management systems, live data streams and built-in analytics to identify trends and help monitor KPIs.
Using GrowBuddy, top-tier producers can observe a 25 percent or more increase in yields. The average for all levels of cultivation expertise is a 50 percent increase in yields. Users of the platform also see a lower than 1 percent crop failure rate, much lower than the industry average of 20 percent.
GrowBuddy is in the process of developing its 2.0 version for the platform. For the purposes of this version, the platform’s interface has been completely redesigned and can be custom-tailored to the specific commercial cultivator. It will also include hardware integration and an IoT hub, which will automatically capture sensor data and add smart controls for both environment and irrigation equipment. The new platform will also include improved multi-user management capabilities.
GrowBuddy has entered into an exclusive agreement with SafeTraces to integrate their products. SafeTraces has developed ‘edible barcodes’ for food products so that each item of food can be traced back to its source. These barcodes are USDA-approved DNA tracers that are extracted from natural sources and are invisible, edible, tasteless and odorless. These can also be applied to cannabis products, during the processing of wet or dry flower and can be tested within minutes.
Once a sample is taken from the product, it can be processed by either a handheld or desktop reader that will then produce metrics tracked on the GrowBuddy system. It will also include regulatory information on each product.
Real World Evidence and Personalized Medicine
The use of IoMT devices to monitor the patient is a more accurate way of gathering real world data (RWD) and, as such, real world evidence (RWE) that can be used in a clinical trial. IoMT devices can provide data on patient compliance with a specific therapy and on patient activities outside the medical facility. This provides objective reporting as opposed to the subjective reporting that a patient might provide about his or her own activities.
IoMT also provides opportunities in the realm of personalized medicine. With the use of monitoring devices that provide real-time data, clinicians can obtain objective data that corresponds to each individual patient. Advancements in the realm of personalized medicine rely on big data capturing technologies, collaboration tools, predictive analytics and decision-supporting tools.
Brian Leeners, BComm, LLB—CEO
Brian Leeners received both his BComm and LLB degrees from the University of British Columbia in 1992 and since that time has been focused on the management of private to public venture companies. In 1997, he joined his first public company where he became President and CEO in 1999. In 2002, he founded Nexvu Capital Corp, which is a venture capital firm focused on developing companies in the Resource and Technology Sectors. He was a founding board member of DigiBC and a former member of the Funding Review Committee in Computers and Computing for the Science Council of British Columbia as well a former member of the Business Advisory Board of the BC Advanced Systems Institute.
Jeffrey Kaye, MD—Chief Medical Advisor
Dr Jeffrey Kaye is the Layton Endowed Professor of Neurology and Biomedical Engineering at Oregon Health & Science University. He is the director of ORCATECH and director of the NIA – Layton Aging and Alzheimer’s Disease Center. His research has focused over the past two decades on understanding healthy aging using a variety of approaches ranging across the fields of genetics, neuroimaging, physiology and continuous activity monitoring. He leads several longitudinal studies of aging including the ongoing Oregon Brain Aging Study, the Intelligent Systems for Detection of Aging Changes (ISAAC) study and the ORCATECH Living Laboratory. The latter studies use pervasive remote sensing and computing technologies for continuous assessment of health and function among older adults in their homes.
He has received the Charles Dolan Hatfield Research Award for his work. He is listed in Best Doctors in America. He serves on many national and international panels and review boards in the fields of geriatrics, neurology and technology including as a commissioner for the Center for Aging Services and Technology (CAST), Chair of the International Society to Advance Alzheimer’s Research and Treatment (ISTAART), a member of the Advisory Board of AgeTech West, and on the Leadership Council of the Network on Environment, Services and Technologies for the American Society on Aging. He is an author of over 300 scientific publications and holds several major grant awards from federal agencies, national foundations and industrial sponsors.
Judith Kornfeld, MBA—COO
Judith Kornfield is the Chief Business and Operations Officer of ORCATECH. Through building worldwide strategic collaborations and alliances while positioning Intellectual Property assets and leveraging products in development, she specializes in bringing innovative medical technologies to prosper in the medical industry. Prior to joining ORCATECH she assumed executive business development positions of emerging medical technological companies in the specialty pharmaceuticals and medical device industries. Recently, she held the position VP of Business Development of TransPharma Medical, a company focused on developing pharmaceutical products based on breakthrough proprietary transdermal drug-delivery technology. She holds a bachelor’s degree in life sciences and an MBA, as well as an academic background in electrical engineering.
Daniel Starbuck—Chief Technology Officer
Daniel Starbuck has over a decade of experience building scalable enterprise business applications for a wide variety of clients, from large Fortune 500 companies to startups. He has extensive experience in the fundamentals of Blockchain. His knowledge and experience are the key drivers to designing and building the secure platform. His role and responsibilities include but are not limited to application architecture, project and staff management, idea and feature development and business strategy integration.
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