Ethics, Compliance and Regulatory Guidance

ICH E6(R3) Guidance: Elevating Trials through Collaboration

Eyewash Stations & Gene Transfer Studies: NIH Guidelines Explained

How Long Should Eyes Be Flushed After Exposure?

The 2025 Avoca State of the Industry Report: Understanding Adoption & Implementation of ICH E6(R3)

Regulatory Evaluations of Companion Diagnostic Medical Devices in Clinical Trials: Experiences of an Independent IRB

ICH E6(R3) Readiness Assessment

Pioneering Ethical Oversight in AI-Enabled Clinical Research: Insights on the New Framework

What Is the Accelerated Approval Pathway? Understanding the Latest FDA Guidance

Review of the FDA Draft Guidance: Considerations for Including Tissue Biopsies in Clinical Trials

The FDA’s Guidance on Electronic Records and Signatures: Key Takeaways