ERT Offers First Patient-Administered ECG Assessment for Continuation of Clinical Trials during COVID-19Posted Apr 23, 2020
ERT Offers First Patient-Administered ECG Assessment for Continuation of Clinical Trials during COVID-19
Patients monitor cardiac safety at home with easy-to-use, FDA-cleared KardiaMobile 6L personal ECG
PHILADELPHIA – April 23, 2020 – ERT, a global data and technology company that captures critical endpoint data while minimizing uncertainty and risk in clinical trials, today announced a first-of-its-kind partnership with AliveCor, the leader in AI-based, personal ECG technology. The partnership enables ERT to capture digital cardiac safety data with KardiaMobile 6L, the only FDA-cleared personal ECG for patient-administered 6-lead data collection.
“By combining AliveCor’s advanced technology with our proven software and workflow platform, we are enabling our customers to continue developing new medical treatments during the COVID-19 pandemic, regardless of whether trial patients have physical access to investigative site personnel,” said Ellen Street, Executive Vice President of Cardiac Safety of ERT. “The device’s ease of use, combined with ERT’s centralized overread and data collection methodology make it an ideal solution for ensuring patient safety during ongoing clinical trials.”
KardiaMobile 6L is a hand-held, 6-lead personal ECG that records Lead II data without the attachment of electrodes. Data captured from the device will be integrated into ERT’s software and workflow platform and read by ERT cardiologists to ensure patient safety during the clinical development of new medical treatments. ERT provides high quality measurements for QTc, QRS, and other ECG intervals that enable efficacy and safety monitoring during clinical trials.
“ERT’s experience in analyzing millions of ECGs and their dedication to patient safety make them the gold standard in clinical trial cardiac safety assessment,” said Priya Abani, CEO of AliveCor. “We look forward to this partnership and to delivering the innovative solutions and valuable data that clinical trial sponsors require.”
Click here to learn more about ERT’s virtual clinical trial capabilities.
ERT is a global data and technology company that minimizes uncertainty and risk in clinical trials so that its customers can move ahead with confidence. With nearly 50 years of clinical and therapeutic experience, ERT balances knowledge of what works with a vision for what’s next, so it can adapt without compromising standards.
Powered by the company’s EXPERT® technology platform, ERT’s solutions enhance trial oversight, enable site optimization, increase patient engagement and measure the efficacy of new clinical treatments while ensuring patient safety. In 2019, 75% of all FDA drug approvals came from ERT-supported studies. Pharma companies, biotechs and CROs have relied on ERT solutions across 15,000 studies, spanning more than four million patients to date. By identifying trial risks before they become problems, ERT enables customers to bring clinical treatments to patients quickly ─ and with confidence.
AliveCor, Inc. is transforming cardiological care using deep learning. The FDA-cleared KardiaMobile 6L device is the most clinically validated personal ECG solution in the world. KardiaMobile provides instant detection of Atrial Fibrillation, Bradycardia, Tachycardia, and Normal rhythm in an ECG. Kardia is the first AI enabled platform to aid patients and clinicians in the early 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 patients and customers' heart conditions simply and profitably using state-of-the-art tools that provide easy front-end and back-end integration to AliveCor technologies. AliveCor was named the No.1 artificial intelligence company in Fast Company's Top 50 Most Innovative Companies. 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.