WIRB-Copernicus Group Expands its Annual International Fellows Program
WIRB-Copernicus Group® (WCG), a provider of regulatory and ethical review services and software to support clinical research, announced its 13th annual WCG International Fellows Program in Research Ethics now includes ethics training at New York University (NYU) Langone Medical Center.
WIRB-Copernicus Group® (WCG), a provider of regulatory and ethical review services and software to support clinical research, announced its 13th annual WCG International Fellows Program in Research Ethics now includes ethics training at New York University (NYU) Langone Medical Center. The program was originally founded in 2002 by Western Institutional Review Board (WIRB), a subsidiary of WCG, in partnership with the World Health Organization (WHO) Research and Training in Tropical Diseases, the National Institutes of Health (NIH), and the University of Washington. The training program is for global healthcare professionals who intend to establish or improve institutional review boards (IRBs) in their countries. It is an intensive six-month program designed to help participants develop the knowledge necessary to create, manage, and/or administer international review boards that will operate in compliance with all relevant regulations and ethics standards intended to protect the rights and welfare of human research subjects.
FDA Grants Priority Review to Merck’s sBLA for Winrevair After Early Success in ZENITH PAH Trial
July 2nd 2025Merck’s bid to update Winrevair’s label advances with FDA priority review, backed by Phase III ZENITH data showing a 76% reduction in major morbidity and mortality events in patients with pulmonary arterial hypertension.
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.
Putting Collective Insights Into Action to Advance Cancer Care: Key Examples From ASCO 2025
June 27th 2025At ASCO 2025, clinical operations leaders gained critical insights into how AI tools, bispecific antibodies, and evolving treatment paradigms are reshaping trial design, endpoint selection, and patient stratification.
