Regulatory Compliance
Artificial Intelligence and Machine Learning in Clinical Trials
FDA Guidance on AI-Enabled Devices: Transparency, Bias, & Lifecycle Oversight
Blog Posts
Biosafety
Best Practices for Protecting Non-Participants in Human Gene Transfer Clinical Trials
Blog Posts
Ethics in Clinical Research
Regulatory Evaluations of Companion Diagnostic Medical Devices in Clinical Trials: Experiences of an Independent IRB
Blog Posts
Regulatory Compliance
ICH E6(R3) Readiness Assessment
Blog Posts
Ethics in Clinical Research
The FDA’s Guidance on Electronic Records and Signatures: Key Takeaways
Blog Posts
Ethics in Clinical Research
Navigating Ethical Challenges: Research with Adults Lacking Capacity to Consent
Whitepapers
Artificial Intelligence and Machine Learning in Clinical Trials
The Role of AI in Regulatory Decision-Making for Drugs & Biologics: the FDA’s Latest Guidance
Blog Posts
Ethics in Clinical Research
The FDA Accepts ICH E11A on Pediatric Extrapolation: How Does This Impact Your Pediatric Study?
Blog Posts
Hybrid & Decentralized Trials
Decentralized Trials: Thoughts for Sponsors, Investigators, and IRBs
Blog Posts
Ethics in Clinical Research