ERT, a leading global solution provider for high-quality patient safety and efficacy endpoint data collection, today announced the availability of MasterScope® 2.0, a new, comprehensive platform for spirometry, ECG, and home monitoring. Especially designed for standardized and centralized clinical trials, MasterScope 2.0 delivers an all-in-one solution that meets the data collection and processing needs of worldwide clinical trial sponsors in the development of medical treatments for respiratory conditions.
MasterScope 2.0 offers complete pulmonary function testing exceeding current ATS/ERS standards, combines home monitoring data from ERT’s AM3 family, and integrates an optional 12-lead digital ECG utilizing the ERT HES® algorithm. And, with the integration of data from third parties like the Aerocrine NIOX Mino® for collecting exhaled nitric oxide (FeNO) into the unique workflow and quality control processor, MasterScope 2.0 represents the most complete solution for clinical data collection and processing needs.
“We understand the challenges investigators face while utilizing various technologies during a complex clinical trial protocol, so we listened closely to them as we developed MasterScope 2.0,” said Achim Schuelke, Executive Vice President and Respiratory Product Line Executive at ERT. “Their feedback led to a very intuitive, appealing user interface and several new features which enable sites to better focus on the patient and the quality of their data.”
MasterScope 2.0 is the only spirometer for clinical trials that provides biometric fingerprint identification that is in compliance with the U.S. FDA’s 21 CFR 11 requirements. The system also automatically maintains a comprehensive audit trail log, facilitating quality and compliance monitoring. Additional smart features, such as the waiting room function make it easier for investigative sites to manage multiple patients on the same visit day and sophisticated procedures for automated quality checks help to improve data quality.
ERT has collected and reviewed over 3.5 million centralized spirometry measurements in more than 500 global clinical trials. To learn more about ERT’s centralized respiratory services and for more information on MasterScope 2.0, visit www.ert.com/respiratory.