Therapy Areas: Devices
Aculys Pharma and Susmed Ink Contract to Conduct the World's First Clinical Trial Utilizing Blockchain Technology
13 July 2022 - - Japan-based neurology and psychiatry drugs developer Aculys Pharma, in has entered into a contract with digital medicine company Susmed to conduct the world's first1 corporate-sponsored clinical trial using blockchain technology, the company said.

The clinical trial utilizing this blockchain technology, provided by SUSMED, will be conducted in collaboration with CMIC Co., Ltd., a specialist in drug development support, with the cooperation of several medical institutions.

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 sandbox.

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 supporting the operation of the system at the medical institution, cooperating with development of the e-worksheet and eCRF, and 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.

Aculys Pharma is a biopharmaceutical company focused on the development and commercialization of innovations in the fields of neurology and psychiatry.

Susmed, Inc. is an R and 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.

CMIC Group was founded in 1992 as the first Contract Research Organization 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 and 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.