CMIC Supports Clinical Trials for Digital Therapeutics Using SUSMED’s Trial Management System
CMIC Co., Ltd. (henceforth “CMIC”)(TYO: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.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201115005172/en/
*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 correctly distributed to each patient, as assigned. For this reason, many processes and tasks differ from general drug development, such as loaning pre-installed, study-specific devices to trial subjects. This results in a heavy burden on companies developing …