Have you ever thought about how your team may interact with a regulator? Is your team prepared to speak about study events, including their responsibilities and contributions to study activities? Does everyone who may be called upon during an inspection know where to find information that supports the evidence of study activities? Do these questions […]
Day: October 13, 2022
Taking the Stress Out of Preparing Investigator Sites for Regulatory Inspection
Inspection site preparations are stressful for everyone involved. Clinical trials are challenging, and they take on a life of their own at each clinical site. Are you ready to have a regulator look into your documentation? Sometimes you think you have everything covered, but a fresh set of eyes may uncover things you did not […]