Clario, a healthcare research technology company that delivers leading endpoint technology solutions for clinical trials, announced an expansion to its collaboration with AliveCor, provider of FDA-cleared personal electrocardiogram (ECG) technology.
The collaboration will enable trial participants to collect medical-grade six-lead ECG readings in their own homes through KardiaRx, a clinical-trial-focused app. The technology enables pharmaceutical and biotech customers to consider decentralized and hybrid clinical trial strategies in study protocols that would have otherwise been limited to on-site evaluations.
“Our partnership with AliveCor is a game-changer for at-home ECG data collection,” said Ellen Street, EVP Cardiac Safety & Respiratory at Clario. “Combining Clario’s scientific expertise and 50 years of experience in cardiac safety with AliveCor’s focus on customizable app functionality will mean pharmaceutical and biotech customers now have new opportunities to incorporate decentralized or hybrid strategies into their study protocol. This not only enables high-quality data collection but also offers a more diverse pool for recruitment and reduced site visits, and ultimately leads to more successful trials.”
AliveCor’s KardiaRx app works with their FDA-cleared KardiaMobile 6L ECG solution, a wireless and user-friendly device that requires minimal training to use. The companion KardiaRx app has been integrated into Clario’s clinical trial platform, which allows site personnel to provide trial participants with a secure connection code for initial setup and login.
This ensures high-quality ECG data is collected seamlessly from the trial participants, while also protecting trial-participant data and eliminating the need for participants to create a new account or provide personally identifiable information.
“Putting FDA-cleared ECG measurement technology in participants’ hands has helped make decentralized clinical trials a reality, and our partnership with Clario brings this capability to even more companies developing the innovative and life-saving therapies of tomorrow,” said Patti Baran, SVP of AliveCor. “Applying our remote monitoring solutions to clinical research advances our vision of becoming the premier provider of end-to-end care for participants when they are not in front of a physician.”