Expanded Access to COVID Therapies in Centralized Hub
Anaqua’s ideaPoint, a provider of medical affairs and innovation management solutions, announced a strategic partnership with clinical data company WideTrial to facilitate greater access to investigational medicines for physicians and patients dealing with COVID-19 worldwide.
The project’s objective is to establish a single centralized hub for access to potentially effective COVID-19 therapeutics through established Expanded Access (EA) regulations. While pharma manufacturers are not enforced to allow EA access to their investigational drugs, the hub is designed to handle demand if EAP are granted. The new platform is designed to allow interested healthcare providers (including non-traditional trial sites, community hospitals, and clinics) to sign up online to participate in the EAPs.
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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.
