Thanks to a company launched last week in the U.K., investigators may soon have the means for capturing certain subject outcomes data with little effort on the part of trial volunteers and clinicians alike.
Isansys makes systems for capturing physiological data (typically vital signs) via low-profile body-worn monitors that operate remotely and continuously. The monitors, part of the IsansysLifecare Platform, interpret the data prior to wireless transmission to a secure data store where they are anonymized and encrypted. The data are then delivered to care providers.
"Although systems based on our platform are not designed to be used as electronic patient reported outcomes tools, the platform provides data that can be integrated into existing tools used in clinical studies and be complementary to the data that they collect," says company co-founder Rebecca Weir in an email. All data are time-stamped, so investigators can correlate physiological information--such as heart rate and respiration rate--with other trial outcomes data.
Isansys uses lightweight and unobtrusive sensors in the body-worn device, dubbed the LifeTouch monitor. It includes data processing algorithms that translate physiological readings into clinical-grade formats, the company says. A small gateway transfers information wirelessly from the sensors into the database.
"Certain components are classed as medical devices and as such require CE certification," says Weir. "We are in process with 13485 quality management system certification." In Europe, however, the MDD exemption for clinical trials applies.
Training to use the system, says Weir, consists of a 20-minute briefing.
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