ERT, a global provider of high-quality patient safety and efficacy endpoint data collection, cloud analytics and workflow solutions, announced that MasterScope 2, its comprehensive diagnostic platform for spirometry, electrocardiogram (ECG) and home monitoring, has been successfully implemented in multiple clinical trials from leading pharmaceutical companies. MasterScope delivers an all-in-one solution that meets and exceeds the data collection and processing needs of worldwide clinical trial sponsors in the development of medical treatments for respiratory conditions such as Asthma and COPD – and also supports sponsors targeting non-respiratory therapies in areas such as oncology and CNS to collect pulmonary safety and disease progression trial endpoints.
350 investigative sites are currently enrolling patients using the advanced MasterScope 2 platform to collect and process important trial endpoint data for spirometry combined with ERT’s AM3 GSM home spirometry, eDiary and the new, integrated12-lead digital ECG. One study is also taking advantage of MasterScope’s seamless integration of the Aerocrine NIOX Mino capturing exhaled nitric oxide (FeNO).
MasterScope 2 offers the most complete solution for clinical data collection and processing needs, helping investigative site personnel to better focus on their patients and the quality of their data. Advanced customization options ensure that protocols are followed precisely and data collection is optimized for maximum quality while ensuring investigator adherence to standards set by the American Thoracic Society (ATS) and European Respiratory Society (ERS).One investigative site coordinator said, “The new user interface of MasterScope 2 is very intuitive and easy to use. Being able to manage subjects and navigate through the patient visit workflows is of great help in following the protocol steps.”
MasterScope 2 is the only 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 smart features, such as the new ‘waiting room’ function, make it easier for investigative sites to manage multiple patients doing serial testing during the day. Sophisticated procedures for automated quality checks also help to improve data quality.
“We’re very pleased that MasterScope 2 has been so well received, and we are eager to continue innovative development of the platform to help investigative site staff concentrate more on patients than on techniques,” said AchimSchülke, Executive VP, Respiratory Solutions at ERT. “At the end of the day, satisfied sites with the right software, processes and data over read solutions from ERT enable us to deliver clean, nearly 100% usable data for our sponsors to empower their efficacy and safety claims with regulatory authorities.”