The clinical trial will be performed in collaboration with CMIC, a Japanese CRO with the cooperation of various medical institutions
Aculys Pharma, a Japanese biopharma company, has signed a contract with digital therapeutics platform SUSMED to carry out a clinical trial using the latter’s blockchain technology.
The clinical trial will be undertaken in collaboration with CMIC, a provider of drug development support (CRO), with the cooperation of various medical institutions.
Aculys Pharma is engaged in developing and commercialising new drugs in the areas of neurology and psychiatry. The biopharma company is said to be working to boost productivity and quality of clinical trials by leveraging artificial intelligence (AI) and digital technologies for bringing new drugs to the market.
SUSMED president and CEO Taro Ueno said: “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.”
SUSMED’s clinical trial system, which will be used by Aculys Pharma, is claimed to help in cutting down data entry work. The system also monitors work by medical institutions by using the company’s patented technology that binds e-worksheets and electronic case report form (eCRF) with the help of blockchain technology.
CMIC’s role will be in promoting the efforts of Aculys Pharma and SUSMED in achieving an efficient clinical trial. For this, the CRO will support the operation of the clinical trial system at the medical institution, cooperate with the development of the e-worksheet and eCRF, and complement the functions that are out of the scope of the system.
Aculys Pharma’s blockchain technology-powered clinical trial is expected to considerably bring down the number of processes around data entry at medical institutions and source data verification (SDV) compared to traditional methods. It will also contribute to cutting down the number of required visits of clinical research associates (CRAs) to medical institutions.
Additionally, by leveraging blockchain technology, the reliability of the clinical trial data is expected to be increased, said Aculys Pharma.
Aculys Pharma president and CEO Kazunari Tsunaba said: “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.”