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 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 commented, “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 Achim Schülke, 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 regulatory authorities.”
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 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 www.ert.com/respiratory.
About ERT
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 as well as data analytics across the trials. 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., Germany, Switzerland, U.K. and Japan.
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