Turning Your Inspection Fears Into Actionable Readiness Steps

Inspection readiness is a vital component of achieving FDA approval for drugs and devices, yet even seasoned clinical research professionals can face challenges in navigating the evolving regulatory landscape. With regulators modernizing clinical trial standards, preparation is key to reducing costs and safeguarding years of investment. Drawing on insights from nearly 100 industry leaders, we present the most common concerns about inspection readiness and a seven-step framework for effective preparation.