Patient-Administered ECG Assessment Enables Clinical Trials to Continue During Pandemic

ERT, a global data and technology company that captures critical endpoint data while minimizing uncertainty and risk in clinical trials, has 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 U.S. Food and Drug Administration-cleared personal ECG for patient-administered six-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, six-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.”
 
On June 10, ERT announced the acquisition of APDM Wearable Technologies, a next-generation provider of wearables and digital biomarkers. The combined company will generate higher-fidelity and more powerful data to enable clinical trials to be more predictable, cost-effective, and efficient. Thereby, reinventing endpoint measurement.
 
Current clinical trial assessments in movement disorders such as Parkinson’s disease, multiple sclerosis (MS), and Ataxia are subjective and based on episodic visits. Consequently, drug development decisions in central nervous system (CNS) and other pathologies result in large-scale trials that are costly and highly unpredictable. APDM’s wearable platform is designed to address these challenges by providing precision motion data collected with medical-grade wearable sensors and novel digital endpoints to guide critical decision-making and allow for more objective, efficient, and effective evaluation of therapies.
 
“We are thrilled that our advanced wearable platform will be added to ERT’s suite of proven eClinical technologies to help innovative clinical trial sponsors minimize uncertainty and risk in the development of CNS and movement disorder treatments, ultimately improving patients’ lives,” said Dr. Mateo Aboy, co-founder and chairman of APDM.
 
As an example, by integrating high-quality patient reported outcomes data captured by ERT’s industry-leading eCOA platform with data from APDM’s wearables and digital endpoints, trial sponsors gain robust insights and more comprehensive safety and efficacy data as they develop new medical treatments for many therapies including movement-related disorders. The integrated solution can be used to support in-clinic assessments as well as in trials conducted virtually.