Healthcare technology firm MC10 has partnered with pharmaceutical company AbbVie to assess the BioStamp nPoint system designed to continuously collect physiological data in clinical trial setting.
The companies will perform clinical studies to investigate various outcome measures in multiple sclerosis (MS) patients using the system, which holds the US Food and Drug Administration (FDA) clearance.
These studies will explore the use of the nPoint system data in offering insights into MS clinical trials.
BioStamp nPoint captures medical grade, clinical bio-metric, physiological and eCOA data and processes it into recognisable clinical metrics such as vital signs, activity/actigraphy and posture classification, sEMG, and sleep metrics.
The collected data is processed and stored in a cloud that can be synched with third party EDC and CTM systems.
AbbVie Development Neurosciences vice-president Dr Michael Gold said: “We are excited to explore the BioStamp nPoint System’s ability to unobtrusively collect clinically relevant data continuously from subjects in more natural settings.
“This technology has the potential to improve the quality of data we collect and at the same time reduce the burden on study participants.”
The system is optimised for in-home as well as in-clinic use. It is designed with multi-modal, multi-location, rechargeable, reusable and wireless sensors that can be applied anywhere on the body, allowing targeted data collection.
It is accompanied by a mobile app that guides users through sensor application, prescribed activities and eCOA.
A web portal is also available for researchers to design and configure their trial, enrol participants, track trial progress and view/extract raw data and processed metrics.
Meanwhile, an investigator app enables assigning of sensors to subjects and viewing streaming data in clinical settings.