Japan’s contract research organisation (CRO) CMIC has employed SUSMED’s trial management system to launch its services covering subject registration, software assignment and distribution to support clinical trials for digital therapeutics (DTx).

By overcoming the common challenges of DTx clinical trials, the system could ensure blinded assignment and prevent unauthorised access.

SUSMED’s trial management system will enable CMIC to cut development costs and offer efficient operations for DTx trials, such as for the assignment and delivery of software applications (apps) to trial participants.

CMIC president Toru Fujieda said: “By introducing SUSMEDʼs trial management system, we hope to overcome some of the security and cost challenges of DTx development.

“We will continue to promote open innovation and the growth of the DTx market in order to answer the needs of clients, healthcare providers and patients as soon as possible.”

The software app is required to be installed on a device, such as a smartphone in a DTx clinical trial.

At the time of using SUSMEDʼs trial management system, each patient will be registered in a secure environment and assigned with an intervention or sham app with a specific ID.

Treatment can be started for the patient with the installation of the app using the issued ID.

With the ID-assignment function, patients will be able to install their assigned app to their personal device, eliminating the need for device rental.

Using the system features, CMIC can effectively complete each DTx clinical trial by formulating the best distribution strategies for each therapeutic intervention.

SUSMED CEO Taro Ueno said: “By providing this trial management system, we hope to contribute to faster and more efficient development of DTx. We will continue to contribute to the growth of DTx by combining SUSMEDʼs technology and CMICʼs comprehensive clinical trial services.”