We are thrilled to announce that we are partnering with global clinical research organization Allucent to support their award with the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). Empatica will assist Allucent with PROJECT REMOTE (REimagining Measurements and Operations of Translational Endpoints), which is a decentralized home focus COVID-19 vaccine trial funded under Project NextGen, an initiative by the U.S. Department of Health and Human Services (HHS) to advance the next generation of vaccines, therapeutics, and enabling technologies.
EmbracePlus will be used to collect continuous, real-time physiological data from 4,000 participants
PROJECT REMOTE plans to enroll 4,000 participants via a decentralized Phase IV observational study to evaluate correlates of protections (CoP) following vaccination with an FDA-approved or authorized COVID-19 vaccine. Allucent will assess the feasibility of remote, self-collected specimens for CoP analysis and integrate wearable devices to potentially forecast COVID-19 infections. Allucent will be utilizing the Empatica EmbracePlus wearable and Empatica Health Monitoring Platform to collect continuous, real-time physiological data from 4,000 participants. Participants will be monitored following vaccination, and EmbracePlus data will be reviewed alongside self-collected specimens.
In a press statement, our CEO and Co-Founder Matteo Lai said:
“We are honored to contribute our technology to this critical initiative. Our previous collaborations with BARDA have already led to significant advancements, such as developing and validating an algorithm that predicts respiratory infections during the pandemic. We look forward to continuing our support of public health emergency preparedness efforts through this initiative, and to leveraging our digital health technologies to advance scientific knowledge and support development of new medical products.”
High-quality data transmitted through the Empatica Cloud API
EmbracePlus and the Empatica Health Monitoring Platform have received FDA clearance for monitoring various physiological signals, including SpO2, pulse rate and skin temperature. Using Empatica's technology to remotely monitor participants will increase accessibility and scale the project across geographical locations, while providing robust, continuous physiological data that can be accessed digitally.
This is a prime example of how our latest platform capability, the Cloud API, can be implemented to scale studies without added complexity. The Empatica Cloud API allows clinical trial sponsors and CROs to adopt our FDA-cleared wearable technology for their studies by directly embedding it in their Clinical Trial Management System (CTMS) of choice and surpassing common operational challenges.
In the case of PROJECT REMOTE, collected data will offer important information on how the body's immune response is related to symptomatic COVID-19 infections, helping to improve the effectiveness of vaccines against new SARS-CoV-2 variants.
If you are interested in talking to our team about how our platform can enhance data collection for your clinical trials, you can easily contact us via this form.
The PROJECT REMOTE study has been funded in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority; under Other Transaction (OT) number 75A50123D00005/75A50123F61002.