PAREXEL has added risk-based monitoring capabilities, expanding its Perceptive MyTrials® Data-Driven Monitoring (DDM) solution. Data-Driven Monitoring now further enables clients to perform cross-study analysis of quality, risk, and monitoring work effort by combining analytics, reporting and monitoring activity into a single cohesive solution. The enhancements increase the ability to demonstrate appropriate oversight and control of site-related risk, quality, and performance while simplifying monitoring governance and execution.
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.