MCC released an in-depth report on risk-based monitoring practices.
MCC released an in-depth report on risk-based monitoring practices, “Taking the Risk-Based Monitoring Plunge: Who’s doing it, how they’re approaching it, and the metrics they’re using to manage it.” The new RBM Report provides current RBM users the ability to compare the RBM methods they currently employ to those utilized by a large sample of biopharmaceutical, CRO and academic research organizations. The report includes over 40 figures, tables and graphs covering a wide range of topics and is available for purchase through MCC.
Read the full release here.
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.