SUSMED System to Accelerate Clinical Trials
Digital Technology to Enhance the Efficiency of Clinical Trials
We developed SUSMED system to enhance efficiency of clinical trials. In drug development, conformity between data obtained during the clinical trial and the medical records needs to be shown to verify that the data has been recorded accurately. Such data verification is normally carried out onsite at medical institutions, but ever since the outbreak of COVID-19 there are concerns that the restrictions on visits to medical institutions may cause delay in drug developments.
On the other hand, by implementing SUSMED system, which employs blockchain technology, there is no longer any need to go to a medical institution like before to verify data. Using the gray zone elimination system of the Japanese competent ministry, we have confirmed that by using SUSMED system properly pharmaceutical company is able to eliminate on-site verification of data at a medical institution.
Digitization in the medical field was thought to be difficult, but we continue to boldly take on new challenges in that field using the power of technology.
On the other hand, by implementing SUSMED system, which employs blockchain technology, there is no longer any need to go to a medical institution like before to verify data. Using the gray zone elimination system of the Japanese competent ministry, we have confirmed that by using SUSMED system properly pharmaceutical company is able to eliminate on-site verification of data at a medical institution.
Digitization in the medical field was thought to be difficult, but we continue to boldly take on new challenges in that field using the power of technology.
Blockchain technology forms the core of the SUSMED system. This technology, which appeared in the field of finance in the 2000s, enables each server (block) to hold data and connect to others with an encryption key (chain) to prevent arbitrary tampering while maintaining information parallelism.
Traditionally, in order to verify the reliability of trial data, the data of medical institutions where a clinical trial was carried out was manually verified with the data of the pharmaceutical company or the research institution (source data validation). But the SUSMED system records patient data in the blockchain, which makes it difficult to tamper with. This makes on-site source data validation unnecessary, meaning that there is a high possibility that the massive personnel expenses associated with clinical trials can be reduced.
Traditionally, in order to verify the reliability of trial data, the data of medical institutions where a clinical trial was carried out was manually verified with the data of the pharmaceutical company or the research institution (source data validation). But the SUSMED system records patient data in the blockchain, which makes it difficult to tamper with. This makes on-site source data validation unnecessary, meaning that there is a high possibility that the massive personnel expenses associated with clinical trials can be reduced.
Before a drug is approved by the competent authority, a long and extensive process is required that involves carrying out clinical trials conducted in strict compliance with the regulations on Good Clinical Practice and the management of associated data. Pharmaceutical companies are engaged in developing drugs, complying with stringent standards that mandate sufficient efficacies and ensure the safety of patients. By offering SUSMED technology to pharmaceutical companies, we aim to see drugs made available to the patients who eagerly await them at appropriate prices as quickly as possible.
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