VivaLNK and Bioclinical are partnering on the remote patient monitoring (RPM) solutions, designed for use in pharmaceutical clinical trials. Users can employ the technology to conduct remote recording and monitoring of changes in various vital signs, including body temperature, heart rate, respiration rate) during the observation period of a trial.
According to VivaLNK, an example of the technology already deployed in the field incorporates the company’s wearable temperature sensor, and Bioclinical’s information management platform for supporting cardiac safety services.
The temperature sensor is applied under the subject’s arm; it continually sends body temperature data to the cloud via a mobile application. The data then is integrated from the cloud into the information management platform, then presented to clinicians and medical teams via a web portal.
Jeff Heilbraun, vice president of medical and scientific affairs at Bioclinica, said the technology will help trial teams collect data in different types of studies.
"Expansion into remote temperature monitoring is a great opportunity to build upon our existing experience in both remote and ambulatory monitoring and to continue to provide our customers with solutions for collecting critical study endpoints and meeting specific regulatory requirements," he explained.
Thomas Fuerst, chief science officer for Bioclinica, said combining wearable sensors with RPM will enable access to data that to date has been hard to capture reliably in remote settings.
"The integration of VivaLNK's innovative RPM technology with Bioclinica's global clinical trial infrastructure will open new paradigms for trial data collection and analysis," Fuerst said.
The VivaLNK continuous temperature sensor enables sites to collect data throughout the course of a 24-hour period, even as the subject is sleeping. The reusable, rechargeable sensor holds a minimum of 7 days of power, enabling data capture over a long period without inconveniencing study participants.
Jiang Li, VivaLNK CEO, pointed out the sensors also could be used in non-trial settings, such as keeping track of the body temperature of patients suffering from COVID-19 and other infections.
According to the companies, future iterations of the RPM solution may include VivaLNK’s multifunction ECG sensor, designed to provide a continuous stream of ECG rhythm, heart rate, respiratory rate, and accelerometer data.