FDA & ICH
Cell & Gene Therapy
How should we handle financial conflicts of interest in FDA-regulated clinical trials?
Blog Posts
FDA & ICH
What are the signature requirements for translated informed consent documents?
Blog Posts
FDA & ICH
What are the IRB submission requirements for observational studies?
Blog Posts
FDA & ICH
Is This an Interventional Clinical Trial or Observational Study? How- and Why- It Is Important to Write Protocols That Make This Distinction Clear
Whitepapers
Cell & Gene Therapy
Addressing the Challenges of Human Tissues and Cell Products Regulation
Whitepapers
Ethics in Clinical Research