Sibel physiological monitoring for clinical trials

  • October 24, 2023
  • Steve Rogerson

Chicago-based digital health company Sibel Health, has released a physiological monitoring platform using wearable sensors for clinical trials.

The Discovery platform is turnkey technology with FDA-cleared wearable sensors for continuous vital signs monitoring and novel digital endpoints.

“We’re proud to be the only monitoring FDA-cleared as a clinical grade sleep test at home and continuous vital signs monitoring for heart rate via ECG, respiratory rate, SpO2, blood pressure and temperature,” said Steve Xu, CEO of Sibel Health. “It’s really exciting to already see top tier pharmaceutical companies and academic institutions signing on as early adopters.”

Sibel Health is collaborating with Medidata, a Dassault Systèmes company and provider of clinical trial options to the life sciences industry, to integrate Discovery into Medidata’s cloud-based platform. The integration will enable biopharmaceutical and medical device companies and clinical research organisations to collect and analyse Sibel sensor data directly from study participants and derive insights sooner.

“Real world, objective data measures are promising in their ability to measure what people care about the most with their specific conditions,” said Xu. “This partnership represents a significant step forward in our mission to provide better data for all and enable clinical trials to run faster with fewer study participants while providing greater clinical insights.”

Melissa Ceruolo, vice president of engineering and biomarker analytics at Medidata, added: “At Medidata, our unwavering commitment is to constantly redefine the boundaries of clinical research, all with the singular aim of expediting life-transforming treatments for patients. By seamlessly integrating Sibel Health’s pioneering monitoring capabilities and digital endpoints into our expansive platform, we are arming researchers with unprecedented tools for ground-breaking discoveries. We are excited at the potential of this partnership to propel clinical trials forward and ultimately transform the practice of healthcare.”

Sibel Health (sibelhealth.com) is a provider of healthcare technology, with FDA clearance for vital signs monitoring capabilities, sleep analysis and novel digital endpoints such as scratch, swallow and cough detection.

Medidata (www.medidata.com) has over 20 years of technological innovation across more than 30,000 trials and nine million patients. It offers expertise, analytics-powered insights and a patient-level historical clinical trial data set.