ERT have announced a cardiac safety solution that helps biopharmaceutical researchers continue important clinical trials during current global Coronavirus ‘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 and treatment of COVID-19, it’s more important than ever for researchers to have access to the tools that meet 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, proven infrastructure, and flexibility to help researchers meet their development objectives; especially now during the uncertain times the industry is facing.”
ERT’s infrastructure enables the normalization and precise over-read of ECGs captured digitally via ERT’s provisioned devices or on paper via site-owned equipment. Investigative site personnel conducting home visits can capture this important safety data and yield comparable values, regardless of how the data was captured. ERT scientists are available to consult with researchers on how ‘at-home’ ECG readings 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 coronavirus quarantines,” said Robert Kleiman, MD, 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.