TOKYO – (BUSINESS WIRE) – Aculys Pharma, Inc. (“Aculys Pharma” Headquarters: Minato-ku, Tokyo, President and CEO: Kazunari Tsunaba), a company focusing on the development and commercialization of new innovative drugs in neurology and psychiatry, has entered into a contract with SUSMED, Inc., a digital medicine marketing company (“SUSMED” Headquarters: Chuo-ku, Tokyo, CEO: Taro Ueno) to implement the world’s first1 company-sponsored clinical trial with blockchain technology. The clinical trial using 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) , in collaboration with several medical institutions.
With the sophisticated research and development and the rising costs of developing new drugs, improving the effectiveness of clinical trials is one of the challenges in the pharmaceutical industry that requires handling. In such an environment, efficient use of resources and the pursuit of efficiency are required. And improving the productivity and quality of new drug development is also extremely important to society as a whole. Under these circumstances, Aculys Pharma works to improve the productivity and quality of clinical trials by using AI and digital technologies for the development and commercialization of new drugs.
The clinical trial system developed by SUSMED enables reduction of data entry work and monitoring work2 of medical institutions using the SUSMED-patented technology that binds e-spreadsheets and eCRFs using blockchain technology. In addition to publishing several medical articles3The clinical research that SUSMED conducted with the National Cancer Center has been approved by the Cabinet Office regulatory sandbox4. The results of the verification test performed by the regulatory sandbox were published in the International Medical Journal in June 20205. With this result, the Ministry of Health, Labor and Welfare issued a notification on 4 December 2020 that source data verification (SDV: Source Data Verification) using blockchain technology is permitted as an alternative method in accordance with the GCP Ministerial Ordinance.
CMIC will promote this effort to achieve effective clinical trials by 1) supporting the operation of the system at the medical institution, 2) collaborating with the development of the e-worksheet and eCRF, and 3) complementing the functions outside the system. .
This clinical study using blockchain technology significantly reduces the number of data entry processes at medical institutions and SDVs compared to conventional methods, and also helps reduce the number of required CRA visits to medical institutions. In addition, by taking advantage of blockchain technology, it is expected to have the effect of increasing the reliability of the actual data from clinical trials. Through these methods, we aim to improve the efficiency of the clinical trial-related workflows necessary for the development of new drugs, and to optimize the development costs of new drugs without compromising reliability.
This clinical study, which uses 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 technology. By leveraging the strengths of each of the three companies, we will work together to achieve improvements in the quality and effectiveness 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 using new technology and external partnerships to solve them.
1 PubMed (a Medical Literature Information Database, and ClinicalTrials.gov (a Clinical Trial Information Database administered by the National Library of Medicine of the National Institutes of Health. EU Clinical Trials Register), and SUSMED research based on other research tools.
2 Monitoring work: work to confirm that clinical trials are conducted correctly in accordance with the protocol. The work also includes verification of source data by checking data from clinical trials by directly browsing the original medical records.
3 Ichikawa et al., 2017, JMIR mHealth uHealth, Motohashi et al., 2019, JMIR
4 A system that was established to promote regulatory reform to accelerate business activities through the use of 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 pleased to be able to conduct a clinical trial using blockchain technology in collaboration with SUSMED and CMIC as Aculys Pharma strives to offer new therapeutic modalities by making full use of the latest in digital technology. We expect this groundbreaking effort from 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 that are not bound by a conventional framework and aim to solve social problems around the Japanese health care system by collaborating and collaborating 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, data tampering prevention and cost-effectiveness have been an issue. While developing therapeutic apps in healthcare, we have come to focus on the possibility of using blockchain technology in clinical development and continue This time, we are pleased to partner with CMIC to conduct the world’s first clinical trial using blockchain technology in a corporate-sponsored clinical trial by Aculys Pharma, a company focusing on the development and commercialization of new innovative drugs. that the use of blockchain technology enables us to realize effective and reliable clinical development, and we can also contribute to optimization and sustainable 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 digitization will also drive process efficiency, we will continue to work to further improve the quality and effectiveness of clinical trials in monitoring work using CMIC’s knowledge based on a range of experience from clinical trials over the last 30 years. ”
About Aculys Pharma, Inc.
Aculys Pharma is a biopharmaceutical company focusing on the development and commercialization of innovations in neurology and psychiatry. The company name was created from the philosophy “Catalyst to Access.” Aculys Pharma aims to act as a bridge for innovative medical treatment in neuropsychiatry, and develops and commercializes new drugs and provides innovations for better medical treatment 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: January 2021
URL:
About SUSMED, Inc.
SUSMED, Inc. is an R & D-oriented company that promotes digital medicine. In addition to providing clinical development support systems using blockchain technology, SUSMED, Inc. develops digital therapies for insomnia and other disorders. SUSMED, Inc. has acquired various patents for medical applications of blockchain technology and digital therapy.
Name: SUSMED, Inc.
Address: 3-7-2 Nihonbashi-Honcho, Chuo-ku, Tokyo
CEO: Taro UENO
Founding: February 2016
URL:
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, offering comprehensive services in drug development, clinical site administration, manufacturing, regulatory consulting and contract sales and marketing solutions. CMIC Group helps pharmaceutical, biotechnology and medical equipment companies enter the Japanese market, conduct clinical trials in Asia, or bridge drug development and manufacturing needs in the United States, Europe, Japan and Asia. CMIC Group has over 7,000 employees and 24 websites globally. For more information about CMIC Group and services, please visit the 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
URL:
[Disclaimer]
Information regarding the pharmaceutical product (compound under development) in this document is not intended as advertising or medical advice, but is intended for the disclosure of management information.
