â€œThe 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,.
PHILADELPHIA February 06, 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.
ERTâ€™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 industryâ€™s most experienced professionals on early phase QT assessments. Companies can also leverage the Centerâ€™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 EXPERTÂ® technology platform, which powers all of the companyâ€™s solutions. EPQT provides significant benefits to drug developers, including earlier, more precise and cost effective cardiac safety assessments.
â€œThe 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,â€� said Alex Zapesochny, Executive Vice President, Cardiac Safety at ERT. â€œHaving overseen 2,000 early phase QT assessments, weâ€™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.â€�
For more information on ERTâ€™s Phase I QT Center of Excellence and EPQT, visit ert.com/cardiac-safety.
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 whatâ€™s next, so it can adapt without compromising standards.
Powered by the companyâ€™s EXPERTÂ® technology platform, ERTâ€™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.
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