PHILADELPHIA – March 22, 2018 – ERT, a global data and technology company that minimizes uncertainty and risk in clinical trials, today announced it has launched a certification program for Phase I investigative sites conducting cardiac safety studies. The program trains sites to collect precise cardiac safety data so that trial sponsors and Clinical Research Organizations (CROs) can determine the cardiac safety of their compounds earlier in development, which can save significant time and money.
The certification program ensures sites are proficient in collecting the highest quality ECG data by conducting Phase I QT assessments using ERT’s proprietary Expert Precision QT (EPQT) approach. EPQT integrates the innovative and broadly-validated analysis methodology for obtaining highly precise ECG data originally developed by iCardiac Technologies, acquired by ERT in 2017, with the ERT EXPERT® technology platform. Phase I units are trained by experts from ERT’s Phase I Center of Excellence to deploy the same ECG/Holter acquisition technology utilized in iCardiac’s landmark IQ-CSRC validation study, which provided evidence supporting the revision of International Council for Harmonisation (ICH) guidelines for testing cardiac safety earlier in development.
“By scaling the site certification program, we are able to expand upon elements previously offered by iCardiac and enhance early-phase ECG data collection across a greater number of sites,” said Alex Zapesochny, ERT’s Executive Vice President of Cardiac Safety. “Drug developers who work with sites already trained in collecting high-quality ECG data can better characterize the effect of a drug on the QT interval within the context of a routine Phase I trial, giving them greater confidence as they make important go/no-go decisions about their compounds earlier during development.”
For more information on ERT’s Site Certification Program and expertise in cardiac safety assessment, visit ert.com/site-certification-program.
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. In 2017, ERT supported more than 60% of all FDA drug approvals. Pharma companies, biotechs and CROs have relied on ERT solutions in 13,000+ studies, spanning more than three 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.