Global Clinical Site Accreditation Launches
Global Clinical Site Accreditation (GCSA) has launched with a commitment aimed at increasing clinical research and trial capacity and quality in the UK, as well as globally. GCSA awards a certification mark through an evidence-based approach.
“As a global clinical research organization, Parexel is focused on working with sites as a partner in the clinical development process,” said Agnieszka Gackowska, Senior Director, Global Site Solutions. “To this end, the ability to pivot in pandemic situations and conduct trials in potentially unpredictable situations—implementing new approaches like decentralized clinical trials—is key...as we work together to bring new therapies to patients in need.”
GCSA is an assessment, improvement, and accreditation organization. A collaboration between Future Shaping Holdings Ltd, the parent company of IAOCR, and Develop Consulting.
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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.
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.
