Regulatory Compliance
Regulatory Compliance
What training documentation is required for conducting clinical research studies?
Blog Posts
Regulatory Compliance
How to resolve irregularities in the documentation of informed consent?
Blog Posts
Regulatory Compliance
Is IRB review required for survey results that may be published?
Blog Posts
Regulatory Compliance
Can we transfer patient data from our CTMS to our parent medical practice?
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
Ethics in Clinical Research
Under the Microscope: Biomarker and Diagnostic Tests as FDA-Regulated Devices
Whitepapers
Cell & Gene Therapy
Addressing the Challenges of Human Tissues and Cell Products Regulation
Whitepapers
Ethics in Clinical Research