FDA & ICH
Ethics in Clinical Research
Drafting a Research Plan for IRB Review and Research Conduct: Information That Must Be Included in a Clinical Trial Protocol
Whitepapers
Ethics in Clinical Research
What are the requirements for notifications of study closure at research sites?
Blog Posts
FDA & ICH
Do all subjects need to be reconsented with the revised consent form?
Blog Posts
Ethics in Clinical Research
Can a protocol get IRB approval during the 30-day IND waiting period?
Blog Posts
FDA & ICH
Does my customer survey project require IRB review?
Blog Posts
Cell & Gene Therapy
The Basics of the Individual Expanded Access Request Process: A Resource for Physicians
Whitepapers
Cell & Gene Therapy
Key Takeaways From FDA’s New Draft Guidance, “Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial”
Blog Posts
FDA & ICH
Can a physician submit a single humanitarian use device (HUD) submission to the IRB?
Blog Posts
FDA & ICH
What documentation needs to be submitted to the IRB for an IND exemption request?
Blog Posts
FDA & ICH