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.
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.
Arcus’ Quemliclustat Earns Orphan Drug Designation as Phase III Pancreatic Cancer Trial Advances
July 11th 2025The FDA has granted orphan status to Arcus Biosciences’ CD73 inhibitor quemliclustat for metastatic pancreatic cancer, as the global PRISM-1 Phase III trial nears full enrollment following promising survival data from ARC-8.
QWINT-1 Trial: Once-Weekly Efsitora Matches Daily Glargine in Type 2 Diabetes Management
July 10th 2025Results from the Phase III QWINT-1 trial show that Eli Lilly’s once-weekly insulin efsitora is noninferior to once-daily glargine in reducing HbA1c among insulin-naïve adults with type 2 diabetes, offering a simplified fixed-dose regimen with fewer hypoglycemic events and less treatment burden.
