EDC : Getting it Right - EDC Rescue Studies INFORMATION TECHNOLOGY : How Health Intelligence Leads to Smarter Research CRO/SPONSOR : The Proactive Advantage in Risk Management Also in this issue : All Eyes on R&D as U.S. Talks Health Care, Fragmented System Stifling EU Research, IT Convergence: Are We There Yet?, Why Virtual Meetings Make Sense
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.
Phase III PROMINENT Trial Initiated to Evaluate Felzartamab for Primary Membranous Nephropathy
June 30th 2025The global Phase III PROMINENT trial has begun dosing patients to evaluate felzartamab in treating primary membranous nephropathy, a serious autoimmune kidney disorder with no FDA-approved therapies.