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Applied Clinical Trials
Advanced diagnostic platform offers ease of use for investigative site staff, protocol adherence, better patient care and higher quality clinical research data
PHILADELPHIA– June 15, 2015 –– ERT, a leading global provider of high-quality patient safety and efficacy endpoint data collection, cloud analytics and workflow solutions,today 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 conditionssuch 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 advancedMasterScope 2 platformto collect and process important trial endpointdata for spirometry combined with ERT’s AM3 GSM home spirometry, eDiary and the new, integrated12-lead digital ECG. Onestudyisalso 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 commented, "The new user interface of MasterScope 2 isveryintuitiveand 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 ofthe platform to help investigative site staff concentrate more on patients than on techniques,” said AchimSchülke, Executive Vice President, Respiratory Solutions at ERT. “At the end of the day, satisfied sites with the right software, processes and data overread solutions from ERT enable us to deliver clean, nearly 100% usable data for our sponsors to empower their efficacy and safety claims with regulatoryauthorities.”
ERT will demonstrate MasterScope and many other original products at its Innovation Lab Booth #2000 and also at the expanded ERT Booth #2025 during the Drug Information Association (DIA) Annual Meeting in Washington, DC beginning June 15, 2015. For more information, visit http://www/ert.com/dia-annual-meeting.
ERT has collected and reviewed over 15 million flow volume loops and many more centralized spirometry measurements in nearly 500 global clinical trials. To learn more about ERT’s centralized Respiratory Solutionsand for more information on MasterScope 2, visit http://www.ert.com/respiratory.