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.
AI in Clinical Trials: A Long, But Promising Road Ahead
May 29th 2024Stephen Pyke, chief clinical data and digital officer, Parexel, discusses how AI can be used in clinical trials to streamline operational processes, the importance of collaboration and data sharing in advancing the use of technology, and more.
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Novel Agent Shows Superiority Over Placebo in Reducing Monthly Migraine Days
September 5th 2024Lu AG09222 shows promise as first-in-class medication that prevents neurogenic inflammation, vasodilation, and parasympathetic lacrimation, which are considered to be surrogate markers of migraine attacks.