Collaboration will improve patient experience and study efficiency through wearable technology – while capturing a wider range of activity and sleep data
- Clario will offer ActiGraph technologies to its customers to complement its suite of eCOA, Precision Motion, Cardiac Safety, Respiratory, Medical Imaging and Trial Enablement solutions
- Clario’s leading Precision Motion offering, the Opal V2C® system, delivers high-fidelity data and analytics that can accelerate study start-up timelines and deliver deeper insights into functional mobility.
- ActiGraph’s FDA-cleared, medical-grade wearable technology captures objective, real-world biometric data related to physical activity, mobility, sedentary behavior and sleep
- ActiGraph’s wearable technology enables clinical trial sponsors to increase the accuracy of continuous passive monitoring and quality of clinical data with real-time digital capture of objective endpoints related to activities of daily living and Quality of Life measures
PHILADELPHIA, June 16, 2022 /PRNewswire/ — Clario, a technology company that delivers the leading endpoint solutions for decentralized (DCT), hybrid and site-based clinical trials, today announced that it is partnering with ActiGraph, a pioneer and leading provider of activity-sensing wearable technology, to further expand its already broad evidence generation platform and portfolio of decentralization technologies. The partnership will help clinical trial sites and sponsors drive efficiency and accuracy while increasing convenience for study participants. Clario will offer ActiGraph technologies to its customers in addition to its suite of eCOA, Precision Motion, Cardiac Safety, Respiratory, Medical Imaging and Trial Enablement solutions.
Quality of Life is increasingly seen as a critical patient reported outcome (PRO) by regulatory bodies as they seek evidence of how clinical interventions change the way patients feel overall. Consequently, activity-related endpoints are required in clinical studies across many therapeutic areas (including oncology, neuroscience, cardiovascular disease, diabetes, obesity and sleep disorders) where patients might be managing their conditions for a prolonged period. Historically, this requirement has imposed a burden on study participants who are asked to submit subjective patient reports. In contrast, ActiGraph’s FDA-cleared, medical-grade platform captures objective, real-world biometric data related to physical activity, mobility, sedentary behavior and sleep. With the proper data science and validation support from ActiGraph and Clario, these data can truly enable clinical trial sponsors to increase the precision, quality and completeness of clinical data by augmenting subjective patient reports and point-in-time clinical outcome data with continuous digital measures.
“We are at an inflection point. Regulatory agencies and patients expect clinical interventions to extend quality, not just length of life,” said Ellen Street, EVP Cardiac Safety and Precision Motion at Clario. “Partnering with ActiGraph allows us to provide our customers with a wider range of measurable and meaningful patient Quality of Life endpoints and is the next step in how we aim to transform lives through technologies that generate the richest clinical evidence.”
Ellen went on to say: “Quality of Life endpoints such as motion and sleep are best measured over extended periods of time and in a range of settings. Decentralized clinical trials can make best use of these endpoints and help bring life-enhancing therapies to market faster. We are proud to offer our customers another key technology that not only enables DCTs but also makes patient participation and site responsibilities less burdensome and activity-related data more precise.”
Built on more than 20 years of real-world data capture expertise, ActiGraph’s fit-for-purpose ecosystem of wearable biosensors, software tools and scientific services delivers digital data in near real-time through a flexible cloud-based technology platform designed around the challenges and complexities of the clinical development process. ActiGraph’s technologies, combined with Clario’s depth of scientific expertise, global scale and existing ability to collect data across a wide range of endpoints, will help ensure complex global trials run smoothly, whether they are on-site, decentralized or hybrid.
“The combination of high-fidelity wearable endpoints deployed on our CentrePoint platform with an industry-leading eCOA tool represents an opportunity to improve the patient experience in modern clinical trials,” said Jeremy Wyatt, CEO at ActiGraph. “The most accurate picture of a patient’s experience comes from a combination of self-reported and high-integrity, objective measurements. Our teams are excited to begin drawing upon Clario’s expertise and providing pharma and biotech companies with our technological and scientific resources, as we both work to advance the development of drugs and therapies.”
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