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.
CONSULTING GxP Services From early discovery to managing your global portfolio, address all your GxP compliance needs and concerns with
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.
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
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.
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.
Navigating research compliance often means addressing unseen challenges. Explore strategies to identify blind spots and strengthen oversight frameworks.
This webinar will tackle the most pressing challenge in clinical research: achieving enrollment targets on time. Our presenters will investigate the recruitment lifecycle across key stages, including vendor referrals, prescreening, consent, and more. Additionally, they will examine how sponsor and CRO study teams can gain better insight into recruitment activities and to predict, analyze, and intervene appropriately.
