In this episode of The Top Line, Olive McCormick joins host Chris Hayden to examine one of the most overlooked risks in clinical research: the last‑minute surprises that can derail a trial. McCormick, who has decades of experience in quality and regulatory leadership, warns that unexpected issues late in the process can jeopardize patient safety, compromise company credibility and stall hard‑won progress.
She emphasizes that avoiding eleventh‑hour problems requires more than good intentions. It demands consistent communication, clear responsibility across teams and a shared understanding of operational and regulatory requirements, including the implications of the new UK Clinical Trial Regulation for study execution.
Hayden echoes this point, noting that success hinges on bringing everyone onto the same page long before a trial reaches a critical milestone.
Their conversation is a reminder that trial execution isn’t just a technical exercise — it’s a coordinated effort that relies on alignment, vigilance and timely action. As McCormick puts it, organizations that take a proactive approach are far better positioned to safeguard their trials and maintain trust with patients and regulators alike.