Aculys Pharma and SUSMED Have Entered into a Contract to Conduct the World's First Clinical Trial Utilizing Blockchain Technology
Aculys Pharma, Inc. ("Aculys Pharma" Headquarters: Minato-ku, Tokyo, President and CEO: Kazunari Tsunaba), a company focused on the development and commercialization of new innovative drugs in the fields of neurology and psychiatry, has entered into a contract with SUSMED, Inc., a company that promotes digital medicine, ("SUSMED" Headquarters: Chuo-ku, Tokyo, CEO: Taro Ueno) to conduct the world's first1 corporate-sponsored clinical trial using blockchain technology. The clinical trial utilizing this blockchain technology, provided by SUSMED, will be conducted in collaboration with CMIC Co., Ltd., (“CMIC” Headquarters: Minato-ku, Tokyo, President: Toru Fujieda), a pioneer in drug development support (CRO), with the cooperation of several medical institutions.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220712005584/en/
With the sophistication of research and development and the increasing cost of new drug development, improving the efficiency of clinical trials is one of the challenges in the pharmaceutical industry that requires addressing. In such an environment, efficient use of resources and pursuit of efficiency are required. And improving productivity and quality of new drug development is also extremely important for society as a whole. Under these circumstances, Aculys Pharma is working to improve productivity and quality of clinical trials by utilizing AI and digital technologies for the development and commercialization of new drugs.
The clinical trial system developed by SUSMED enables the reduction of data entry work and monitoring work2 by medical institutions by using the SUSMED-patented technology that binds e-worksheets and eCRF using blockchain technology. In addition to publishing multiple medical papers3, the clinical research that SUSMED conducted with the National Cancer Center has been approved by the Cabinet Office regulatory sandbox4. The result of the verification test conducted by the regulatory sandbox was published in the International Medical Journal in June 20205. With this outcome, The Ministry of Health, Labor and Welfare issued a notice on December 4, 2020 that source data verification (SDV: Source Data Verification) using blockchain technology is permitted as an alternative method under the GCP ministerial ordinance.
CMIC will promote these efforts for attaining an efficient clinical trial by 1) supporting the operation of the system at the medical institution, 2) cooperating with development of the e-worksheet and eCRF, and 3) complementing the functions outside the scope of the system.
This clinical trial which utilizes blockchain technology significantly reduces the number of processes around data entry at medical institutions and SDV compared to conventional methods, and also contributes to reducing the number of required CRA visits to the medical institutions. In addition, by taking advantage of blockchain technology, it is expected to have the effect of increasing the reliability of the clinical trial data itself. Through these methods, we aim to improve the efficiency of the clinical trial-related work-streams necessary for new drug development, and to optimize new drug development costs without compromising reliability.
This clinical trial utilizing blockchain technology, which is a pioneering effort to solve medical problems in Japan, is joined by CMIC, Japan's first CRO company willing to adopt new technologies. By leveraging the strengths of each of the three companies, we will collaborate to achieve improvements in the quality and efficiency of clinical trials. These three companies will continue to contribute to Japanese society by identifying medical issues from a social point of view and by actively utilizing new technologies and external partnerships to resolve them.
1 PubMed (https://pubmed.ncbi.nlm.nih.gov/), a medical literature information Data Base, and ClinicalTrials.gov (https://pubmed.ncbi.nlm.nih.gov/), a clinical trial information Data Base managed by the National Library of Medicine of the National Institutes of Health. https://www.clinicaltrials.gov/), EU Clinical Trials Register (https://www.clinicaltrialsregister.eu/ctr-search/search), a clinical trial information Data Base of the European Medicines Agency, and SUSMED research based on other research tool.
2 Monitoring work: work to confirm that clinical trials are being conducted properly according to the protocol. Work also includes source data verification by checking clinical trial data by directly browsing the original medical records.
3 Ichikawa et al., 2017, JMIR mHealth uHealth, Motohashi et al., 2019, JMIR
4 A system that established to promote regulatory reform for accelerating business activities using new technologies and business models based on the Act on Special Measures for Productivity Improvement.
5 Hirano et al., 2020, JMIR
Kazunari Tsunaba, President and CEO of Aculys Pharma, Inc., stated as follows.
"We are delighted to be able to conduct a clinical trial utilizing blockchain technology in collaboration with SUSMED and CMIC as Aculys Pharma strives for providing new therapeutic modalities by making full use of the latest in digital technology. We expect this pioneering effort of three companies, which aim to improve the quality and efficiency of clinical trials, will realize digital transformation of clinical trial monitoring work and contribute to the optimization of new drug development costs. We will continue to actively introduce new technologies not bound by a conventional framework and aim to solve social issues surrounding Japanese healthcare by collaborating and partnering with external partners."
Taro Ueno, President and CEO of SUSMED, Inc., stated as follows.
"In the clinical trials conducted in the development of new medical technology, prevention of data tampering and cost efficiency have been issues. While developing therapeutic apps in the healthcare field, we have come to focus on the possibility of using blockchain technology in clinical development and continued research and development. This time, we are delighted to be able to collaborate with CMIC to conduct the world’s first clinical trials using blockchain technology in a corporate-sponsored clinical trial of Aculys Pharma, a company that focuses on the development and commercialization of new innovative drugs. We believe that utilization of blockchain technology enables us to realize efficient and reliable clinical development and we also can contribute for optimization and sustainability of future social security.”
Toru Fujieda, President of CMIC Co., Ltd., stated as follows.
"CMIC was established in 1992 as Japan's first CRO and has supported a number of clinical trials of drug development. This time we are participating in the corporate-sponsored clinical trial of Aculys Pharma with SUSMED. While digitalization will furthermore drive acceleration of process efficiency, we will continue to pursue further improvement of quality and efficiency of clinical trials in monitoring work by utilizing CMIC's know-how based on numerous clinical trial experiences over the past 30 years."
About Aculys Pharma, Inc.
Aculys Pharma is a biopharmaceutical company focused on the development and commercialization of innovations in the fields of neurology and psychiatry. Its corporate name was created from the philosophy of "Catalyst to Access." Aimed to act as a bridge for innovative medical care in the field of neuropsychiatry, Aculys Pharma develops and commercializes novel pharmaceuticals and provides innovations for better medical care to patients, their families, healthcare professionals, and society.
Company name: Aculys Pharma, Inc.
Address: 2-14-4 KitaAoyama, Minato-ku,Tokyo, Japan
Representative: Kazunari Tsunaba
Established: Jan 2021
About SUSMED, Inc.
SUSMED, Inc. is an R&D-oriented company that promotes digital medicine. In addition to providing clinical development support systems that utilize blockchain technology, SUSMED, Inc. develops digital therapeutics for insomnia and other disorders. SUSMED, Inc. has acquired various patents for medical applications of blockchain technology and digital therapeutics.
Name: SUSMED, Inc.
Address: 3-7-2 Nihonbashi-Honcho, Chuo-ku, Tokyo
CEO: Taro UENO
Founding: February 2016
About CMIC Group
CMIC Group was founded in 1992 as the first Contract Research Organization (CRO) in Japan. Today CMIC Group is the largest clinical CRO in Japan with a global footprint, providing comprehensive services in drug development, clinical site management, manufacturing, regulatory consulting and contract sales & marketing solutions. CMIC Group helps pharmaceutical, biotech and medical device companies to enter the Japanese market, to conduct clinical trials in Asia, or to bridge drug development and manufacturing needs in the US, Europe, Japan and broader Asia. CMIC Group has over 7,000 employees and 24 sites globally. For more information about CMIC Group and services, please visit website below.
Company name: CMIC Co., Ltd.
Address: Hamamatsucho Bldg., 1-1-1 Shibaura, Minato-ku,Tokyo
Representative: Toru Fujieda
Established: Established in March 1985, opened in 1992
Information concerning pharmaceutical product (compound under development) contained herein is not intended as advertising or as medical advice, but intended for disclosure of management information.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
[Contact information for the press]
Aculys Pharma Public Relations Secretariat (within Brains Company, Inc.)
Tel: +81-3-4580-6124 Mail: email@example.com
CMIC HOLDINGS Co., Ltd.
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Bakken Energy Reaches Key Application Milestone for $1.7b Loan Guarantee From the U.S. Department of Energy28.9.2022 12:00:00 CEST | Press release
Bakken Energy, through its subsidiary Great Plains Hydrogen, LLC, has been invited by the U.S. Department of Energy’s Loan Programs Office (LPO) to submit a Part II application under the Title XVII Innovative Clean Energy Loan Guarantee Program. The invitation is an important milestone in Bakken’s process in applying for DOE financing for $1.7 billion of Bakken’s $2.35 billion clean hydrogen project. Established via Title XVII of the Energy Policy Act of 2005, the DOE-backed loan, if awarded after DOE reviews the Part II application and completes subsequent due diligence, will support the acquisition of the Great Plains Synfuels Plant in North Dakota and its redevelopment into a world class production facility with low-cost clean hydrogen. Achieving this invitation to the Part II process is a key milestone for Bakken in the Department of Energy’s LPO process. The invitation states that “while this invitation from the DOE LPO does not guarantee or imply that Great Plains Hydrogen, LLC w
Regnology Announces its 29 th Annual RegTech Convention on 29 th – 30 th November28.9.2022 09:00:00 CEST | Press release
Regnology, a leading software provider with an exclusive focus on regulatory reporting solutions has announced its 29th annual RegTech Convention, taking place on the 29th-30th November in Frankfurt, Germany and virtually. The convention will bring together nearly 2,000 delegates across regulatory authorities, supervisory agencies, and financial institutions to explore the evolving trends in regulation. The theme for this year’s convention is Regulation 3.0, which will be explored across 30 keynotes and panel discussions from leading industry experts and Regnology subject matter experts. Over thirty external speakers will discuss how the regulatory complexity for financial institutions can be reduced in view of a challenging global economic environment, the pressure to maximize cost efficiencies, and an evolving financial market landscape. Fredrik Reinfeldt, Swedish prime minister from 2006-2014, will address the current political and economic challenges in Europe and how it affects th
Cadmatic Acquires Italian Engineering Software Company CLA28.9.2022 09:00:00 CEST | Press release
The acquisition is a further step in fulfilling Cadmatic’s strong growth strategy, which sees the company more than tripling its size in coming years. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220926005546/en/ Jukka Rantala (left) and Gian Mario Tagliarett (Photo: Business Wire) EPC contractors and plant owner-operators use CLA’s software to manage piping materials and piping supports, construction sites, multidisciplinary engineering data, online tenders, project planning and plant welding. CLA was established in 2001 and employs 22 staff at its office in Piacenza, 70 km south of Milan. “CLA is a perfect strategic fit for us. They have impressive references, especially in the key area of multinational EPC companies and our offerings have no overlapping functionalities. By integrating CLA’s materials and construction management products with Cadmatic’s design, engineering, and information management solutions, we can of
Mavenir Announces 2G, 4G and 5G Open RAN Radios Made in India28.9.2022 07:30:00 CEST | Press release
Mavenir, the Network Software Provider building the future of networks with cloud-native software that runs on any cloud and transforms the way the world connects, today announced to have commenced the production of 2G, 4G and 5G Open RAN Radios for the OpenBeam™portfolio in India, for Indian and other prominent worldwide bands. OpenBeam offers an innovative radio portfolio, cost-efficient, intelligent radios that meet the critical demands placed on today’s networks including massive MIMO, mmWave and multi-band remote radio heads (RRHs) allowing improved network capacity as the network expands. The OpenBeam Open RAN radio solutions are available across all frequency bands and can be used for a wide range of use cases, including enterprises and public settings across urban or rural environments. Mavenir’s robust set of radio options address the needs of the CSPs to be agile and cost-efficient with low power consumption, low wind load, and built with integrated intelligence and automatio
Tigo Energy Surpasses One-Terawatt Hour of Monitored Solar PV Energy in Europe28.9.2022 07:00:00 CEST | Press release
Tigo Energy, Inc., the solar industry's leading Flex MLPE (Module Level Power Electronics) supplier, today announced that the solar energy monitoring function in the Tigo Energy Intelligence Solution has logged more than one Terawatt hour of photovoltaic energy generated by customer systems in the European market. Powered by the Tigo TS4 family of MLPE products, the Energy Intelligence Solution reports high-precision, module-level monitoring of solar installations. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220927006003/en/ The initial residential installation for The Ipv6 Company was in Galapagar, near Madrid. This 9.5kW system serves both home and office with a small data center. (Photo: Business Wire) With PV installations across Europe expected to grow by 40 GW in 2022, solar continues to take a leading position as the clean energy production method of choice throughout the region. With the Tigo Energy Intelligence (
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.Visit our pressroom