SITES : CTMS - Site Productivity Gains Why You Need This 10-Step Public Relations Plan UK Network for Pediatric Research Also in this issue : REMS Addresses Opioids, Adverse Events Assessment in Europe, Academia, NIH Above Repute?, Financial Impact on CROs
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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.
Astegolimab Shows Mixed Results in COPD Trials, Meeting Endpoint in ALIENTO but Not in ARNASA
July 24th 2025Astegolimab met its primary endpoint in the Phase IIb ALIENTO trial with a 15.4% reduction in annualized exacerbation rate at 52 weeks, while the Phase III ARNASA study showed a 14.5% reduction and did not meet the primary endpoint.