According to The Tufts-eClinical Solutions Data Strategies & Transformation Study, conducted in 2019 by eClinical Solutions LLC and the Tufts Center for the Study of Drug Development, the increasing volume and diversity of external data sources is contributing to longer database lock cycle times. The study indicates that industry leaders are adopting definitive data strategies along with modern technologies to increase control over the research process.
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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.