ERT’s AM3® Is First Integrated Home Spirometer/eDiary Authorized To Administer Standardized Asthma And COPD Instruments
6/17/2014 1:56:24 PM
Measuring Home Spirometry combined with Administration of ACQ and/or EXACT-PRO Increases Data Reliability while Reducing Trial Costs
PHILADELPHIA – June 17, 2014 –– ERT, a leading global solution provider for high-quality patient safety and efficacy endpoint data collection, today announced that its AM3® meter is the only integrated home spirometer and electronic Diary (eDiary) authorized to implement the most commonly used standardized instruments for both asthma and chronic obstructive pulmonary disease (COPD) clinical trials. The instruments are Professor Elizabeth Juniper’s Asthma Control Questionnaire (ACQ) and the Exacerbations of Chronic Pulmonary Disease Tool-Patient Reported Outcome (EXACT-PRO) diary.
These authorizations enable ERT to offer biopharmaceutical researchers an ideal solution for capturing both PROs and expiratory flow-volume parameters such as PEF and FEV1 on a single device. By providing patients with just one easy-to-use device, trial sponsors will benefit from increased protocol compliance and data reliability while reducing hardware and overall trial costs.
“By offering both the ACQ and EXACT-PRO instruments on our AM3 home spirometer, we are providing biopharmaceutical researchers with a reliable, all-in-one solution for capturing important patient information as they develop new respiratory medical treatments,” said Achim Schuelke, Executive Vice President and Respiratory Product Line Executive at ERT. “We are pleased to provide a proven, integrated solution that delivers accurate and reliable respiratory and symptomatic data while reducing patient and site burden during clinical trials.”
With nearly 80,000 AM3 devices used in worldwide clinical trials since 2009, ERT has the proven respiratory experience that sponsors can trust. To learn more about ERT’s centralized respiratory services and for more information on ERT’s enhancements to the AM3 family of devices, visit https://www.ert.com/respiratory.
ERT (www.ert.com) is a leading provider of high-quality patient safety and efficacy endpoint data collection solutions for use in clinical drug development. ERT delivers a combination of technology, services, and consulting that increase the accuracy and reliability of patient data and improve the efficiency of the clinical development process throughout the product lifecycle. ERT delivers the most widely deployed solutions in centralized cardiac safety, respiratory services, suicide risk assessment and Clinical Outcome Assessments (COAs) – which includes patient, clinician, and observer reported outcomes. By efficiently integrating these solutions through a system built upon a scientific and regulatory foundation, ERT collects, analyzes, and delivers safety and efficacy data critical to the approval, labeling, and reimbursement of pharmaceutical products. ERT is a global organization with headquarters in Philadelphia, PA and offices throughout the U.S., U.K., Japan, and Germany.
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