ERT, a global solution provider for high-quality patient safety and efficacy endpoint data collection, has launched MasterScope2.0, 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. It also integrates data from third parties such as the Aerocrine NIOX Mino for collecting exhaled nitric oxide (FeNO) into the unique workflow and quality control processor.
MasterScope 2.0 is a spirometer for clinical trials that provides biometric fingerprint identification, 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 features, such as the waiting room function, make it easier for sites to manage multiple patients on the same visit day, and procedures for automated quality checks help improve data quality.
ERT has collected and reviewed over 3.5 million centralized spirometry measurements in more than 500 global clinical trials.