CMIC Co., Ltd. (henceforth “CMIC”)(TOKYO:2309) has launched services using SUSMED, Inc.’s (henceforth “SUSMED”) trial management system covering subject registration, software assignment and distribution for digital therapeutics (DTx).
The system is able to overcome the common challenges of DTx clinical trials, ensuring blinded assignment and preventing unauthorized access. By employing this system, CMIC will offer more efficient operations for DTx trials, such as for the assignment and delivery of software applications (apps) to trial participants, cutting development costs.
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*The system allows for seamless management of both intervention/sham app assignment and app distribution. (Graphic: Business Wire)
In a DTx clinical trial, the software app must be installed on a device, such as a smartphone. Additionally, a placebo app (sham) is often used as a control in comparison to the actual treatment app (intervention), so it is essential that each app is