Blog Posts
Ensuring Representative US Enrollment in Oncology Clinical Trials: Navigating the Rising Tide of Regulatory Scrutiny
Blog Posts
Eyewash Stations & Gene Transfer Studies: NIH Guidelines Explained
Blog Posts
How Long Should Eyes Be Flushed After Exposure?
Blog Posts
FDA Guidance on AI-Enabled Devices: Transparency, Bias, & Lifecycle Oversight
Blog Posts
Regulatory Evaluations of Companion Diagnostic Medical Devices in Clinical Trials: Experiences of an Independent IRB
Blog Posts
ICH E6(R3) Readiness Assessment
Blog Posts
Pioneering Ethical Oversight in AI-Enabled Clinical Research: Insights on the New Framework
Blog Posts
What Is the Accelerated Approval Pathway? Understanding the Latest FDA Guidance
Blog Posts
Review of the FDA Draft Guidance: Considerations for Including Tissue Biopsies in Clinical Trials
Blog Posts