Applied Clinical Trials Digital Edition - November 2009
GLOBAL TRIALS : South Africa?s Positioning Fosters Healthy Trial Landscape Croatia?s Dynamic Qualities CROs Must Manage Italy?s Regulatory Makeover EDC?s Evolution in Japan Also in this issue : Postmarketing Pushes Back Approvals, EU Regulators Increase Involvement, Site Shake-Out Benefits Those That Remain, Is in Silico Modeling the Economic Solution?
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.
