ERT has partnered with AliveCor, a company specializing in artificial intelligence (AI) based personal electrocardiogram (ECG) technology. The collaboration will enable ERT to capture digital cardiac safety data via KardiaMobile 6L, currently only FDA-cleared personal ECG for patient-administered 6-lead data collection.
Ellen Street, executive vice president of cardiac safety with ERT, told Outsourcing-Pharma that the company saw the need to provide clinical trial teams with ECG options that enabled trials to continue during the pandemic, while maintaining patient safety.
“We selected the KardiaMobile 6L as the best option for a reduced lead self-administered ECG that provides Lead II data digitally to support measurement of QT, QRS, and other ECG findings for clinical trials,” she said. “AliveCor also was interested in expanding their technology into the clinical trial space and in working with ERT as a recognized leader in cardiac safety for clinical trials and assessment of important endpoints like QT."
KardiaMobile 6L is a hand-held, 6-lead personal ECG that records Lead II data without the need to attach electrodes. Data captured using 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.
“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,” Street said. “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.”
ERT provides measurements for QTc, QRS, and other ECG intervals that enable efficacy and safety monitoring during clinical trials. Pria Abani, AliveCor CEO, said ERT brings to the table a track record of offering ECG data analysis and patient-centric solutions.
“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,” she said. “We look forward to this partnership and to delivering the innovative solutions and valuable data that clinical trial sponsors require.”
In addition to the KardiaMobile 6L project, Street told us her company will continue exploring ways to help clinical research organizations continue their work in the face of the pandemic.
“ERT is continuing to enhance our virtual trial capabilities and will be introducing additional, novel solutions over the coming weeks to help our customers continue their important clinical trials and confidently capture the safety and efficacy data needed to demonstrate the effectiveness of new medical treatments,” she said.
