ERT, a global provider of 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 with 350 investigative sites.
ERT, a global provider of 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 with 350 investigative sites currently enrolling patients using the advancedMasterScope 2 platform. The platform collects processes 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).
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
FDA Grants Priority Review to Merck’s sBLA for Winrevair After Early Success in ZENITH PAH Trial
July 2nd 2025Merck’s bid to update Winrevair’s label advances with FDA priority review, backed by Phase III ZENITH data showing a 76% reduction in major morbidity and mortality events in patients with pulmonary arterial hypertension.