“Clinical trial sponsors can now leverage ERT’s expertise in adapting clinical trial protocols to the new guidelines so that they can have confidence in the veracity of their clinical trial data and develop new respiratory treatments more efficiently.” - Achim Schülke, Executive Vice President, ERT.
PHILADELPHIA (PRWEB) July 23, 2020
ERT, the global leader in clinical endpoint data collection, today announced it has significantly enhanced its industry-leading spirometry data collection systems to capture more accurate, research-grade lung function data to support the development of new respiratory treatments and documenting of disease progression. These enhancements make it the industry’s first respiratory solution to achieve full compliance with standards issued by the American Thoracic Society and European Research Society (ATS / ERS) in 2019.
Historically, high levels of spirometry data variability were considered to be acceptable in clinical trials, potentially obscuring true treatment effects and leading to prolonged development timelines and increased costs in respiratory drug development. As a result, in 2019 ATS/ERS issued new standards for manufacturers, clinicians, operators, and researchers with the aim of increasing the accuracy, precision, and quality of spirometric measurements and improving the patient experience.
“We’re pleased to add the industry’s first complete ATS/ERS 2019-compliant respiratory solution to the long list of innovations ERT has introduced to help our customers bring new treatments to patients sooner,” said Achim Schülke, Executive Vice President, Respiratory Solutions at ERT. “Clinical trial sponsors can now have confidence in the veracity of their clinical trial data and leverage ERT’s expertise in adapting clinical trial protocols to the new guidelines so that they can further reduce data variability and develop new respiratory treatments more efficiently.”
ERT’s spirometry collection devices and data management solution are configurable to each respiratory trial’s unique protocol, delivering the highest data quality in accordance with these new guidelines, and helping trial sponsors meet other clinical development objectives.
“The ATS/ERS standards are driving a new era of data quality by reducing the incidence of implausible data and changes in function associated with suboptimal coaching,” said Kevin McCarthy, Member, Proficiency Standards for Pulmonary Function Laboratories Committee, American Thoracic Society and a member of the ATS/ERS Task Force that produced the updated spirometry standards. “Thanks to the new guidelines, sponsors will gain better insight into treatment effects, which will help prioritize their pipelines and focus their development efforts on drug candidates that are the most viable and safe.”
For more information visit ERT at the ATS Virtual Conference, August 5-10, or 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. In 2019, 75% 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.