Clario and AliveCor collaborate to offer advanced, trial-focused six-lead ECG solutions for monitoring in decentralized clinical trials
Collaboration brings the next generation of cutting-edge ECG technology to trial participants’ homes, enabling accurate cardiac safety trial measurements with fewer site visits.
- 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 resolve PII issues and associated sponsor risk with the commercial-use Kardia app and features a simplified user workflow to help avoid protocol deviations.
PHILADELPHIA, PA – August 15, 2023 – 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.”
For more information about AliveCor’s KardiaRx app capabilities, please go to Clario.com.
Clario is a leading healthcare research and technology company that generates the richest clinical evidence in the industry for our pharmaceutical, biotech and medical device partners. Across decentralized, hybrid and site-based trials, our deep scientific expertise, global scale and the broadest endpoint technology platform in the industry allows our partners to transform lives. Clario has the only technology platform that combines eCOA, cardiac safety, medical imaging, precision motion, and respiratory endpoints. Clario’s global team of science, technology and operational experts have helped deliver more than 27,000 trials and contributed to over 500 FDA and EMEA new drug approvals involving more than seven million participants in over 100 countries. Our innovation has been transforming clinical trials for 50 years.
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AliveCor, Inc. is transforming cardiological care using deep learning. The FDA-cleared KardiaMobile device is the most clinically-validated personal ECG solution in the world. KardiaMobile 6L provides instant detection of Atrial Fibrillation, Bradycardia, Tachycardia, Sinus Rhythm with Supraventricular Ectopy, Sinus Rhythm with Premature Ventricular Contractions, Sinus Rhythm with Wide QRS, and Normal Sinus Rhythm in an ECG. Kardia is the first AI-enabled platform to aid participants and clinicians in the efficient detection of atrial fibrillation, the most common arrhythmia and one associated with a highly-elevated risk of stroke. AliveCor’s enterprise platform allows third-party providers to manage their participants’ and customers’ heart conditions simply using state-of-the-art tools that provide easy front-end and back-end integration to AliveCor technologies. AliveCor protects its customers with stringent data security and compliance practices, achieving HIPAA compliance and SOC2 Type 1 and Type 2 attestations. AliveCor is a privately-held company headquartered in Mountain View, Calif. “Consumer” or “Personal” ECGs are ECG devices available for direct sale to consumers. For more information, visit alivecor.com.