Copernicus Group IRB Receives ISO 9001:2008 Certification
Copernicus Group IRB (CGIRB) announced that it has received ISO 9001:2008 Certification, affirming that the company’s quality management system meets the strict qualifications for the globally accepted ISO standard.
The ISO 9001:2008 standard outlines requirements and provides guidance on good quality management systems for businesses and other organizations. Achieving ISO 9001:2008 certification demonstrates that CGIRB’s quality management system consistently provides products and services that meet customer needs.
As an independent institutional review board (IRB), CGIRB is dedicated to ensuring the rights and welfare of research study participants. ISO 9001 Certification is just one example of the quality assurance process that goes into maintaining this top-tier independent institutional review board. A web portal and a paperless operational workflow that meets all 21 CFR Part 11 compliance requirements are part of CGIRB’s tireless efforts on behalf of human research study participants.
FDA Outlines Updated Requirement for Placebo-Controlled Trials in Vaccine Research
May 21st 2025In an article recently published by The New England Journal of Medicine, FDA higher-ups Vinay Prasad, MD, MPH; and Martin A. Makary, MD, MPH, wrote that any new COVID-19 vaccine must now be evaluated in placebo-controlled studies.
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.
Full Phase IIIb BATURA Trial Results Show Airsupra Cuts Severe Exacerbations by 47% in Mild Asthma
May 20th 2025Results from the pivotal BATURA trial show that Airsupra (albuterol/budesonide) significantly outperformed albuterol monotherapy in reducing severe asthma exacerbations and systemic corticosteroid exposure, reinforcing its role as a next-generation, anti-inflammatory rescue therapy for mild asthma patients.
