Clinical trials have increased in number and complexity for numerous reasons-global trials, outsourcing, protocol requirements, and multiple regulatory issues. Factor this with the increased need to bring efficiencies and lower prices to the clinical trial process, and the need to stay on top of trials only becomes more crucial. This eBook will include articles on logistics of clinical trials supplies, negotiating with investigative sites, use of e-signatures and more.
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.