Compliance
From Simulation to Success: Stress Testing Your Inspection Readiness
Gain expert insights, best practices, and strategies to navigate FDA inspections with confidence.
The Regulatory Binder Checklist For Clinical Trial Sites
This checklist offers a comprehensive framework for managing all necessary essential regulatory documents efficiently.
Sponsors: Are Your Sites Ready for an FDA Inspection?
Learn a comprehensive overview to prepare sponsors and sites for an FDA inspection.
Is Your Site Ready for an FDA Inspection?
Understand the FDA’s expectations for a site inspection, GCP compliance, and maintaining study integrity.
The IND Journey Phase I – Navigating Success
Explore strategies for advancing investigational new drug (IND) submissions and a comprehensive guide through Phase I of the IND journey.
Getting “Engaged” in the Time of COVID
When using remote sites to perform clinical trial procedures, keep in mind things like whether remote sites are considered "engaged" in research. Read more: