Regulatory Compliance
CenterWatch | Insights
Ensuring Representative US Enrollment in Oncology Clinical Trials: Navigating the Rising Tide of Regulatory Scrutiny
Blog Posts
CenterWatch | Insights
FDA Guidance on AI-Enabled Devices: Transparency, Bias, & Lifecycle Oversight
Blog Posts
CenterWatch | Insights
Regulatory Evaluations of Companion Diagnostic Medical Devices in Clinical Trials: Experiences of an Independent IRB
Blog Posts
CenterWatch | Insights
ICH E6(R3) Readiness Assessment
Blog Posts
CenterWatch | Insights
The FDA’s Guidance on Electronic Records and Signatures: Key Takeaways
Blog Posts
CenterWatch | Insights
The Role of AI in Regulatory Decision-Making for Drugs & Biologics: the FDA’s Latest Guidance
Blog Posts
CenterWatch | Insights
The FDA Accepts ICH E11A on Pediatric Extrapolation: How Does This Impact Your Pediatric Study?
Blog Posts
CenterWatch | Insights
Decentralized Trials: Thoughts for Sponsors, Investigators, and IRBs
Blog Posts
CenterWatch | Insights
Compounded Drugs in Research: Navigating IND Exemptions and Current Regulations
Blog Posts
CenterWatch | Insights