Applied Clinical Trials Digital Edition - March 2010
REGULATORY : Rediscovering the Role of Regulatory Scientists CRO/SPONSOR : Trends in Clinical Outsourcing Language Lessons for Global Sponsors SITES : The ABCs of SOP Best Practices Also in this issue : FDA Works to Modernize Health IT System, Health Technology Assessment Brews in EU, Sizing Up the Clinical Research Market, Patients Tune In to Recruitment
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.
