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.
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.
First Patient Dosed in Phase III Trial of Enhertu as First-Line Treatment for Endometrial Cancer
June 10th 2025In combination with rilvegostomig or Keytruda, Enhertu will be evaluated versus chemotherapy in the DESTINY-Endometrial01 study for the treatment of patients with HER2-expressing, mismatch repair proficient primary advanced or recurrent endometrial cancer.
