Insights
Clinical Endpoints
Supporting NDA Submission for a Drug Targeting Menopausal Vasomotor Symptoms
Case Studies
Ethics in Clinical Research
Ethical Biosafety Oversight of Gene Transfer Research
Whitepapers
Clinical Trial Safety
Do we need to submit safety events from another site to our IRB?
Blog Posts
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
Series: Ask the IRB & IBC Experts
Can participants be reconsented over the phone when an ICF is updated?
Blog Posts
FDA & ICH
What are the IRB submission requirements for observational studies?
Blog Posts
Questions on regulations for process development and purchased human cells
Blog Posts
Regulatory Compliance
What training documentation is required for conducting clinical research studies?
Blog Posts