Ethics in Clinical Research
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
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
Ethics in Clinical Research
How Do PIs Report PRI in a Blinded Study Without Unblinding Themselves?
Blog Posts
Ethics in Clinical Research
Do You Need to Submit an Updated Protocol to the IBC After Already Receiving Approval?
Blog Posts
Ethics in Clinical Research
Compounded Drugs in Research: Navigating IND Exemptions and Current Regulations
Blog Posts
Ethics in Clinical Research