Resources

Explore our comprehensive Resources hub, featuring insightful articles, tools, case studies, and webinars to advance your knowledge in Risk-Based Quality Management, clinical trials, and regulatory compliance. Stay up-to-date with industry trends and best practices for success.

Feb 2025

Site Readiness Under ICH E6(R3): Key Guidance for Sponsors

By |2025-02-26T22:37:15+02:00February 26, 2025|Blog, Free Infographics, News, Resources|Comments Off on Site Readiness Under ICH E6(R3): Key Guidance for Sponsors

Discover how the finalized ICH E6(R3) guideline elevates site and sponsor collaboration, emphasizing robust training, resource allocation, and digitally empowered data governance. This concise article outlines critical updates, from risk-based monitoring to formalized documentation, ensuring your clinical trial operations align with leading edge GCP requirements and maintain the highest standards of patient safety and data integrity.

Jan 2025

Adopting ICH E6(R3): What Sponsors, CROs, Sites, and Participants Need to Know

By |2025-02-26T14:59:07+02:00January 16, 2025|Blog, Free Infographics, Good Clinical Practice, News, Resources|Comments Off on Adopting ICH E6(R3): What Sponsors, CROs, Sites, and Participants Need to Know

The ICH E6(R3) guideline was formally adopted on January 6, 2025, introducing reinforced principles for clinical trial conduct. This final version builds on its draft with clarified expectations and some notable revisions. Let’s explore the highlights and the implications for stakeholders.

Dec 2023

Decoding the ICH’s Q9(R1) Quality Risk Management Guideline

By |2025-02-26T15:04:16+02:00December 4, 2023|Blog, Free Infographics, Good Clinical Practice, News, Resources|Comments Off on Decoding the ICH’s Q9(R1) Quality Risk Management Guideline

Explore the impact of ICH's Q9(R1), Quality Risk Management, guideline on RBQM and clinical trials in our latest blog post. Don't miss our free infographic that simplifies this complex guideline. Enhance your risk strategies today!

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