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 31, 2026 | Subscriber Articles
Inspection readiness has evolved. In 2026, it’s no longer enough to have a clean TMF, a strong monitoring plan, or a successful mock inspection on file. Regulators and stakeholders increasingly expect organizations to demonstrate that quality, oversight, and risk...
by Kimberly | May 29, 2025 | Blog Articles
Audit readiness isn’t an event—it’s a habit.For Clinical Research Associates (CRAs), juggling competing timelines and complex protocols, that mindset is everything. Being inspection-ready doesn’t begin when the FDA calls. It’s built visit by visit, query by query, and...
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...
