Evidera and CSS Collaborate in Japan
Evidera has entered into an exclusive collaboration agreement with Clinical Study Support, Inc., a subsidiary of Shin Nippon Biomedical Laboratories Ltd. to provide research services to global or Japan-based clients undertaking studies that include a Japanese component. Additonally, they intend to explore further opportunities to expand their joint capabilities in data analytics and management, epidemiology, biostatistics, medical writing and qualitative research.
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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.
