- First contract research organization (CRO) to explore use of Rockley’s Bioptx™ biomarker sensing platform for non-invasive monitoring of multiple biomarkers during clinical trials
- Rockley Bioptx™wearable devices set to transform clinical research by enabling decentralized trials, generating crucial insights into the health and well-being of participants
Rockley Photonics Holdings Limited (NYSE: RKLY) (“Rockley”), a global leader in photonics-based health monitoring and communications solutions, today announced a new partnership with a top ten, global contract research organization (CRO) that provides full-service clinical development services to biopharmaceutical customers. Under the agreement, the CRO and Rockley will collaborate on strategic programs to integrate Rockley’s health monitoring solutions into clinical research studies, including its Bioptx™ biosensing wristband, cloud services, and other elements of its biomarker sensing platform for continuous, near real-time, non-invasive measurement of multiple biomarkers. The addition of Rockley’s wearable devices and artificial intelligence (AI) capabilities to clinical research has the potential to enable decentralized trials, increase the frequency and accuracy of vital sign monitoring, and expand the range of biomarker information collected from research participants, whether at a clinic or in a remote location.
In this collaboration, the CRO is expected to use Rockley-powered remote monitoring wearables as a tool for researchers to better understand various factors affecting the health and well-being of trial participants. The Rockley Bioptx wristbands will potentially allow the CRO to collect in-depth data about an expanded range of biomarkers, including core body temperature, blood pressure, heart rate, blood oxygen, and body hydration, among others. By gathering and analyzing data on key biomarkers, this new partnership has the potential to enhance the opportunity for the Rockley platform to provide pharmaceutical companies and healthcare professionals with a more thorough understanding of how specific treatments and interventions affect a patient’s overall health.
Traditional approaches in clinical trials have relied primarily on intermittent assessments of biological data, usually gathered by on-premises tests performed at a designated trial site or clinic. By leveraging Rockley’s remote biosensing capabilities, CROs could expand the boundaries of clinical trials beyond the confines of a clinic by monitoring participants as they go about their daily lives. This greater flexibility could allow CROs to broaden the types of trials conducted — e.g., in-clinic, virtual, hybrid, and decentralized — thereby extending data assessments into situations closer to real-world conditions. The integration of Rockley’s cloud analytics and AI capabilities could allow CROs to develop a deeper understanding of trial results and the interactions of various biomarkers and health conditions.
Rockley expects that the comprehensive data produced by its biosensing wristbands could have a significant impact on study design, patient selection, and go/no-go decisions. Rockley-powered devices have the potential to improve patient recruitment and compliance, as patients would need to make fewer office visits. Additionally, adhering more closely to the trial protocol requirements would be simplified, reducing protocol deviations. The anticipated decrease in site visits would also reduce site and resource burden, leading to cost savings.
Dr. Andrew Rickman, chairman and chief executive officer of Rockley, said, “Partnering with CROs expands our reach in medtech and creates exciting opportunities for clinicians and researchers to conduct decentralized clinical trials and gain crucial insights into the health and well-being of patients throughout the trial, regardless of their location. With the extended range of biomarker detection and the ability to monitor those biomarkers on a routine basis, Rockley-powered wearables are poised to add a new dimension to clinical research and bring us one step closer to realizing our goal of improving health outcomes for everyone.”
More information about Rockley’s digital health monitoring solution is available here: https://rockleyphotonics.com/healthcare-sensing
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