ERT At-Home Cardiac Safety Assessment Ensures Trial Continuity


Applied Clinical Trials

ERT, a global data and technology company that captures critical endpoint data, has announced a cardiac safety solution that helps biopharmaceutical researchers continue important clinical trials during current global ‘stay home’ mandates. The solution enables clinician-administered ECG readings-using ERT’s provisioned, FDA-cleared devices or other investigative site-owned equipment-to evaluate the safety of new vaccines and medical treatments from patients’ homes.

Clinical site visits by patients may not be possible as healthcare providers focus their efforts on patients who require urgent care as a result of the COVID-19 pandemic. In order to keep their clinical trials on track, biopharmaceutical researchers need innovative solutions that enable safety and efficacy data to be collected from patients’ homes.

“With so many new compounds being developed and fast-tracked through FDA for the prevention andtreatment of COVID-19, it’s more important than ever for researchers to have access to the tools thatmeet their development timelines while keeping patient safety at the forefront,” said Ellen Street,Executive Vice President of Cardiac Safety of ERT. “We’re pleased to apply our expertise, proveninfrastructure, and flexibility to help researchers meet their development objectives; especially now duringthe uncertain times the industry is facing.”

ERT’s infrastructure enables the normalization and precise over-read of ECGs captured digitally viaERT’s provisioned devices or on paper via site-owned equipment. Investigative site personnel conductinghome visits can capture this important safety data and yield comparable values, regardless of how thedata was captured. ERT scientists are available to consult with researchers on how ‘at-home’ ECGreadings can ensure patient safety while keeping both their current and new trials on track.

“With ERT’s At-home ECG solution, clinical researchers can continue assessing the cardiovascular risk of new medical treatments, even while patients are adhering to local and nationally mandated quarantines,” said Robert Kleiman, VP, Cardiology, and Chief Medical Officer, ERT. “By capturing these readings remotely, researchers can evaluate the cardiovascular effects of new medications and enable patients to continue treatment, which may be critical for those with life-threatening conditions.”

ERT offers additional capabilities that enable remote patient data collection for trial continuity, including respiratory trial support for spirometry and ECG assessments conducted by investigative site personnel in the patient’s home.

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