ERT’s At-Home Cardiac Safety Assessment Ensures Clinical Trial Continuity
Company’s expertise, infrastructure and flexibility enable remote ECG assessment for fast-tracked COVID-19 vaccines /therapies and other critical pharmaceuticals
PHILADELPHIA – March 30, 2020 – ERT, a global data and technology company that captures critical endpoint data while minimizing uncertainty and risk in clinical trials, today 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 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 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.
Click here to learn more about ERT’s virtual 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. Since 2013, more than half 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.