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Clario has announced an expansion to its collaboration with AliveCor. This collaboration will enable trial participants to collect medical-grade six-lead electrocardiogram (ECG) readings in 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, a wireless, personal ECG solution. 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 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."
Clario and AliveCor collaborate to offer advanced, trial-focused six-lead ECG solutions for monitoring in decentralized clinical trials. (2023, August 15). Cision PR Newsire.