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 Finalizes Decentralized Clinical Trial Guidance
November 25th 2024The FDA's guidance is part of a broader effort to modernize clinical trials, improve efficiency, reduce participant burden, and expand access, particularly for underrepresented populations and those in geographically or economically constrained areas.
Driving Diversity with the Integrated Research Model
October 16th 2024Ashley Moultrie, CCRP, senior director, DEI & community engagement, Javara discusses current trends and challenges with achieving greater diversity in clinical trials, how integrated research organizations are bringing care directly to patients, and more.
AI in Clinical Trials: A Long, But Promising Road Ahead
May 29th 2024Stephen Pyke, chief clinical data and digital officer, Parexel, discusses how AI can be used in clinical trials to streamline operational processes, the importance of collaboration and data sharing in advancing the use of technology, and more.
Patient Engagement Platform Checklist
November 22nd 2024Modern clinical trials are more complex than ever, and one significant reason is the increased focus on patient engagement. Incorporating a patient engagement platform into your clinical trial enhances the patient experience and can lead to more successful trials with stronger, more reliable outcomes. We put together this helpful checklist of key features to look out for when choosing a platform for your study.
The Rise of Predictive Engagement Tools in Clinical Trials
November 22nd 2024Patient attrition can be a significant barrier to the success of a randomized controlled trial (RCT). Today, with the help of AI-powered predictive engagement tools, clinical study managers are finding ways to proactively reduce attrition rates in RCTs, and increase the effectiveness of their trial. In this guide, we look at the role AI-powered patient engagement tools play in clinical research, from the problems they’re being used to solve to the areas and indications in which they’re being deployed.
