Clario, AliveCor Partner for Advanced Six-Lead ECG Solutions in Decentralized Trials

KardiaMobile 6L 6-lead EKG view

• Clario and AliveCor provide a new trial-participant-friendly solution for cutting-edge, at-home data collection with privacy protection, instrumental in situations where traditional 12-lead ECG cannot be collected.
• The KardiaRx app is the next-generation, comprehensive and customized solution that allows trial participants to easily collect medical-grade six-lead ECG readings from their own homes, helping facilitate recruitment and improve retention rates.
• The KardiaRx app resolves PII issues and associated sponsor risk with the commercial-use Kardia app and features a simplified user workflow to help avoid protocol deviations.

Clario, a healthcare research technology company that delivers leading endpoint technology solutions for clinical trials, today announced an expansion to its collaboration with AliveCor, the global leader in FDA-cleared personal electrocardiogram (ECG) technology. This collaboration will enable trial participants to collect medical-grade six-lead ECG readings in the comfort of their own homes through KardiaRx, a clinical-trial-focused app. This 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.

AliveCor's KardiaRx app works with their FDA-cleared KardiaMobile^® 6L, the most clinically validated personal ECG solution in the world, a wireless and user-friendly device that requires minimal training to learn how 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.

"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." 

"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."