Solution enables sponsors and sites to continuously monitor axillary body temperature while the patient is at home or in a clinical research unit
VivaLNK, a leading provider of connected healthcare solutions, and Bioclinica, the leader in Medical Imaging, Cardiac Safety services and technology-enabled solutions in clinical research, today announce a remote patient monitoring (RPM) solution for pharmaceutical clinical trials. Designed for at-home monitoring of subjects on an automated basis, the solution enables remote recording and monitoring of continuous changes in one or more vital signs (e.g., body temperature, heart rate, respiration rate) during the observation period of a trial.
One example of this remote monitoring solution that is already deployed for clinical trials uses VivaLNK’s wearable temperature sensor and Bioclinica’s information management platform developed to support cardiac safety services. The temperature sensor, applied to the subject’s underarm, continuously sends axillary body temperature to the cloud via a companion mobile application. From the cloud, the data are then integrated into the Bioclinica information management platform and presented to clinicians and study sponsor medical teams using a web portal.
Bioclinica’s cardiac safety team was an early advocate of centralized capture of telemonitored data through the integration of a home blood pressure monitoring solution that has been successfully employed in both efficacy and safety-focused global clinical trials.
“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,” said Jeff Heilbraun, MS, VP, Medical & Scientific Affairs at Bioclinica.
The combination of advanced wearable sensors and RPM is enabling access to clinical data that was previously difficult 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,” said Thomas Fuerst, Ph.D., Chief Science Officer at Bioclinica.
The benefit of using the VivaLNK continuous temperature sensor allows the capture of data throughout an entire 24-hour period even during sleep. The sensor is reusable and rechargeable with a minimum of 7-day power, which offers data capture over a long period of time that is both convenient and unobtrusive for study participants.
“We’re proud to be working with Bioclinica to bring RPM solutions to the world of clinical trials,” said Jiang Li, CEO at VivaLNK. “In addition to clinical trials, VivaLNK’s continuous temperature sensor is used within hospitals to monitor patient infections, including the fight against COVID-19.”
Future phases of the combined VivaLNK and Bioclinica RPM solution can include the use of VivaLNK’s multifunction ECG sensor, which provides a continuous stream of ECG rhythm, heart rate, respiratory rate, and accelerometer data.
Source: Company Press Release