PHILADELPHIA-February 6, 2018-ERT, a global data and technology company that minimizes uncertainty and risk in clinical trials, today announced the establishment of a Phase I QT Center of Excellence, which enables pharmaceutical companies, biotechs and Clinical Research Organizations (CROs) to gain actionable and highly reliable information about the cardiac safety profile of their drug candidates at the earliest possible time in the drug development process.
ERT’s Phase I QT Center of Excellence combines scientific expertise with advanced technology to give clinical trial sponsors confidence in the data they need to determine the safety of new medical products and meet regulatory requirements. The Center represents the first significant Cardiac Safety service enhancement that leverages the capabilities of iCardiac Technologies and Biomedical Systems, both of which were acquired by ERT in 2017.
Staffed by scientists and clinicians who have shaped and driven cardiac safety advancements for the past 25 years, the Center enables trial sponsors and CROs to collaborate with some of the industry’s most experienced professionals on early phase QT assessments. Companies can also leverage the Center’s dedicated team of in-house statisticians, who deliver data reliability metrics through Method Bias Sensitivity (MBS) analysis and enable dose escalation and other time-sensitive decisions via an expedited Agile Statistical Reporting (ASR) service.
In tandem with the Center, ERT has launched Expert Precision QT (EPQT), an integrated ECG analysis platform designed specifically for Phase I studies. EPQT integrates the innovative and broadly-validated analysis methodology for obtaining highly precise ECG data originally developed by iCardiac Technologies with the ERT EXPERT® technology platform, which powers all of the company’s solutions. EPQT provides significant benefits to drug developers, including earlier, more precise and cost effective cardiac safety assessments.
“The Phase I QT Center of Excellence gives researchers the resources they need to capitalize on recent regulatory changes regarding Thorough QT study alternatives and ultimately save considerable time and money when conducting cardiac safety assessments,” said Alex Zapesochny, Executive Vice President, Cardiac Safety at ERT. “Having overseen 2,000 early phase QT assessments, we’ve proven that the optimal combination of science and technology delivers the high-quality data needed to make important go / no-go decisions and to accelerate the development of safe and effective new medical treatments.”
For more information on ERT’s Phase I QT Center of Excellence and EPQT, visit ert.com/cardiac-safety.
###
About ERT
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 2014, more than half of all FDA drug approvals came from ERT-supported studies. Pharma companies, Biotechs and CROs have relied on ERT solutions in 10,000+ 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 â and with confidence.
AI in Clinical Trials: A Long, But Promising Road Ahead
May 29th 2024Stephen Pyke, chief clinical data and digital officer, Parexel, discusses how AI can be used in clinical trials to streamline operational processes, the importance of collaboration and data sharing in advancing the use of technology, and more.
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.