Applied Clinical Trials presents the latest issues that have risen to prominence since RBM adoption grows. This edition presents a well-rounded look at RBM including articles that describe current RBM trends; a survey of European CRAs, which shows the difficulties among sites and monitors with RBM; a comprehensive look at how sponsors and CROs can support their employees in the RBM transition, and closes with a case study on Novartis' use of adaptive monitoring.
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.