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PHILADELPHIA-February 8, 2018-ERT, a global data and technology company that minimizes uncertainty and risk in clinical trials, today announced advanced respiratory clinical trial services that centrally collect lung function data using the Forced Oscillation Technique (FOT). This solution is available immediately for trials of asthma, COPD and other respiratory conditions.
Used in combination with FEV1 and other protocol endpoints, FOT enables trial sponsors to monitor airway resistance, reactance and other lung function parameters by assessing small airways, where changes can be detected earlier than with spirometry and imaging assessments. Since it only requires patients to breathe normally into a mouthpiece with minimal instruction, FOT reduces patient and investigative site burden and overcomes the challenges associated with performing proper spirometry maneuvers, especially in elderly and pediatric patients.
Centralized FOT Services deliver easy to use, efficient FOT measurement via Thorasys’ tremoflo® device and ERT’s industry-leading MasterScopeTM spirometry platform. Through integration with tremoflo, MasterScope provides clear workflow management and patient guidance with real-time signal displays, all of which improve protocol compliance and data quality.
“We’re pleased to offer this centralized FOT solution and look forward to rapidly expanding it to support additional devices our customers are using in their clinical research,” said Achim Schülke, Executive Vice President, Respiratory Solutions at ERT. “We are committed to continuing ERT’s rich heritage of innovative respiratory solutions that help trial sponsors meet their development objectives while maintaining regulatory compliance so they can move ahead quickly, and with confidence.”
For additional information on ERT’s Centralized FOT Services â which can be integrated with imaging, eCOA and Cardiac Safety endpoint data for more comprehensive views of drug safety and efficacy â visit ert.com/respiratory.
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 quicklyâand with confidence.