DENVER–(BUSINESS WIRE)–ClinOne, an industry leader in virtual clinical trial patient management, continues to expand its platform with FDA-approved wearable technology to capture 15 remote digital endpoints. Featuring continuous vital sign and behavioral monitoring, ClinOne provides real-time insight into biometric data, sleep and activity levels, and symptomatic or adverse event (AE) indicators, without adding patient burden or introducing compliance risk.
“Objective measurement data used for endpoint analysis are too important to leave to chance”
Digital endpoints captured automatically by passive wearable monitoring include:
- Biometrics: heart rate at rest, respiratory rate, skin and core body temperature
- Behavioral monitoring: body position, activity level, sleep status
- Symptomatic data: fall detection, cough and sneeze detection, AE indicators
Additionally, ClinOne collects task-based endpoints, such as blood pressure, pulse oximeter readings, and electrocardiogram results. Patients are responsible for taking these endpoints at specific times and are reminded with alerts through ClinOne’s patient concierge solution to ensure timeliness and improve compliance. Endpoints are provided in near-real-time through encrypted cellular data.
“Objective measurement data used for endpoint analysis are too important to leave to chance,” says Rob Bohacs (LinkedIn), co-founder and CEO of ClinOne. “And while patients want to provide clean data, typical compliance and accuracy are notoriously low. It is our responsibility to capture reliable data without getting in the way of patients’ everyday lives. Our expanded offerings for FDA-approved wearable technology improves study conduct by providing real-world evidence you can trust, while reducing, and in many cases eliminating, the need for site visits to maintain patient safety oversight.”
Through the ClinOne platform, the company allows pharmaceutical sponsors, research sites, and clinical trial participants to perform and automate key clinical trial operational tasks including clinical trial recruitment, study execution, compliance, and patient retention from any location worldwide. ClinOne’s modules span patient recruitment, remote consent (eConsent), patient reported outcomes and surveys (ePRO), dosing management, and remote vital sign management data collection – all seamlessly integrated with home healthcare visits and telemedicine video visits – to advance clinical research into the post-COVID-19 era.
“At our core, we are passionate that technology can do so much more than digitize the flawed processes of the past. In fact, we believe it is the collective responsibility of ClinOne and other industry providers to enable new insights, new safety measures, and new levels of data analytics previously thought impossible, without adding burden to patients, sites, or study teams. Wearable technology can be a big piece of that puzzle, which is why we are so pleased and proud to expand our offering of at-home digital endpoints to improve the accuracy and effectiveness of decentralized clinical trials,” says Bohacs.
The ClinOne solution and its suite of products are proven to accelerate clinical trial enrollment and remote patient care, compliance, and retention. The company’s sole mission is to strengthen connectivity and management of participating researchers, patients, and caregivers on-site and remotely. ClinOne’s systems are HIPAA, FDA CRF 21 Part 11, and GDPR compliant and validated, and have been used across 55 countries by more than 50 sponsors and 90,000 investigators since 2016. Learn more at www.clinone.com.
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