The Pistoia Alliance has launched a new series of programs to help organizations collaborate on advancing the role of digital technology within life sciences R&D and healthcare. As part of the Pistoia Alliance’s strategic refresh, defined by its 2030 vision report, the Alliance has created this initiative to bring together all stakeholders with an interest in digital health technologies; the goal is to develop projects that deliver real, tangible outcomes. The project will analyze how a digital, real-world data collection tool is used during a clinical trial, aiming to define standards for collecting patient-centric data in a way that provides value for a particular therapeutic area.
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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.