by Kimberly | Apr 30, 2026 | Subscriber Articles
Unannounced FDA inspections are one of the most revealing moments in clinical research. Without warning, they expose whether inspection readiness, GCP compliance, and quality systems are truly embedded in daily operations—or dependent on last-minute preparation. In...
by Kimberly | Mar 27, 2025 | Blog Articles, Subscriber Articles
When the FDA comes knocking, two issues often top the list of inspection findings: lack of Principal Investigator (PI) oversight and failure to follow the protocol. These aren’t minor slip-ups. They can delay a study, jeopardize data integrity, or even halt your...
by Kimberly | Feb 27, 2025 | Subscriber Articles
In the world of clinical research and FDA inspections, documentation is more than just a regulatory requirement—it is the backbone of compliance, transparency, and credibility. Inaccurate or incomplete records can jeopardize studies, lead to regulatory findings, and...
by Kimberly | Feb 4, 2025 | Blog Articles, Subscriber Articles
Clinical trials drive medical advancements by developing safe and effective treatments. However, a major issue threatens their reliability—lack of diversity. When trials exclude participants from different racial, ethnic, and socioeconomic backgrounds, the data does...
