The third revision (R3) of the ICH E6 Guideline for Good Clinical Practice represents a significant modernization of global clinical research standards. Research organizations must critically evaluate both their clinical priorities and operational procedures to ensure compliance.
The release of ICH E6(R3) in January 2025 marks the most significant evolution in Good Clinical Practice (GCP) guidelines in over a decade. More than a revision, E6(R3) marks a shift from traditional practices—making participant safety and data reliability not just priorities, but design drivers, and introducing risk-based proportionality as a foundational approach.
Join experts from Johnson & Johnson Innovative Medicine, Bayer, The START Center for Cancer Care, and Advarra to discuss the ethical use of real-world data in clinical research.
The release of ICH E6(R3) in January 2025 marks the most significant evolution in Good Clinical Practice (GCP) guidelines in over a decade. More than a revision, E6(R3) marks a shift from traditional practices—making participant safety and data reliability not just priorities, but design drivers, and introducing risk-based proportionality as a foundational approach.
Clinical research drives medical progress. Advarra ensures participant safety and ethical standards through expert IRB oversight for life-changing therapies.
Making Just-in-Time Oncology Trials Work: Overcoming Barriers and Unlocking Potential As part of Oncology Research Pulse, our new thought leadership
Launched in January 2025, the Association of Multisite Research Corporations (AMRC) was set up by its founding members to advance
Timelines for study start-up affect everything from budgets and drug pricing to a site’s ability to secure trials. This webinar
Navigating research compliance often means addressing unseen challenges. Explore strategies to identify blind spots and strengthen oversight frameworks.
Our webinar discusses key near-term trends and regulations and investigate persistent challenges frequently throwing even the most efficient teams off track. Advarra and industry representatives will dive deeper into achieving critical milestones across study startup, conduct, and close out that every project manager should optimize.
This white paper examines four KPIs most impacting timelines and budgets and offers strategies for effective communication and risk mitigation.
This white paper examines four KPIs most impacting timelines and budgets and offers strategies for effective communication and risk mitigation.
