ERT Introduces Express Overread Service for Respiratory Clinical Trials

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One-hour turnaround time eliminates ineligible trial participants; saves sponsors time and money

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“By enabling investigative sites to quickly identify and enroll only those patients who meet inclusion criteria, our customers can accelerate clinical development timelines and more quickly bring new drugs to the patients who need them.” -Achim Schülke

ERT, a global data and technology company that minimizes uncertainty and risk in clinical trials, today announced the availability of its Express Overread service for clinical trials that require spirometry and pulmonary function testing (PFT). The service provides centralized overread of PFT results in one hour or less, enabling investigative sites to quickly and reliably determine which patients are eligible to be included and randomized in clinical trials.

“Respiratory drugs are among the most expensive to develop, primarily due to the challenges investigative sites face in identifying eligible patients and following accurate clinical trial data collection processes,” said Achim Schülke, Executive Vice President, Respiratory Solutions at ERT. “By accessing PFT overread feedback within one hour or less, investigative site personnel can make accurate inclusion or exclusion determinations while the patient is still in the office, reducing the risk of randomizing the wrong patients, which often results in skewed data and longer development timelines.”

Express Overread is available for all clinical trials that use EXPERT®, ERT’s platform for centralized clinical trials. The service enables faster enrollment decision-making in any clinical trial that requires spirometry measurements, including those that also collect fractional exhaled nitric oxide (FeNO), diffusing capacity of the lungs for carbon monoxide (DLCO) and lung clearance index (LCI) data as well as electrocardiogram (ECG), home spirometry, and electronic Clinical Outcome Assessment (eCOA) data.

“With costs for new clinical development continuing to rise, sponsors and CROs are looking for ways to bring new medications to market faster and more efficiently,” continued Schülke. “By enabling investigative sites to quickly identify and enroll only those patients who meet inclusion criteria, our customers can accelerate clinical development timelines and more quickly bring new drugs to the patients who need them.”

For more information on ERT’s respiratory solutions, visit stand R.05 at the European Respiratory Society International Congress in Milan, Italy through September 13, or visit ert.com/respiratory.

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 more than 40 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 9,500+ studies spanning 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. For more information, go to ert.com or follow us on LinkedIn and Twitter.

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Christine Tobin
ERT
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