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.
Merck Launches Phase III Trials of Once-Monthly Oral HIV PrEP Candidate MK-8527
July 14th 2025In the new EXPrESSIVE clinical trial program, Merck will evaluate MK-8527, a once-monthly, oral PrEP therapy, in populations at high risk of HIV-1 infection, including adolescent girls and women in sub-Saharan Africa.
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.
Baxdrostat Shows Significant Blood Pressure Reduction in Phase III BaxHTN Trial
July 14th 2025In the BaxHTN Phase III study, AstraZeneca’s baxdrostat demonstrated statistically significant and clinically meaningful reductions in systolic blood pressure in patients with uncontrolled or treatment-resistant hypertension.
New FDA Initiative Reveals Common Reasons for Drug Application Rejection
July 11th 2025By publishing more than 200 complete response letters, the FDA is offering new visibility into the issues that most often delay drug approvals, including safety concerns, trial design flaws, and manufacturing gaps.
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.
