Regulatory Compliance
Ensuring Representative US Enrollment in Oncology Clinical Trials: Navigating the Rising Tide of Regulatory Scrutiny
Blog Posts
FDA Guidance on AI-Enabled Devices: Transparency, Bias, & Lifecycle Oversight
Blog Posts
Best Practices for Protecting Non-Participants in Human Gene Transfer Clinical Trials
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
The FDA’s Guidance on Electronic Records and Signatures: Key Takeaways
Blog Posts
Navigating Ethical Challenges: Research with Adults Lacking Capacity to Consent
Whitepapers
The Role of AI in Regulatory Decision-Making for Drugs & Biologics: the FDA’s Latest Guidance
Blog Posts
The FDA Accepts ICH E11A on Pediatric Extrapolation: How Does This Impact Your Pediatric Study?
Blog Posts