Clinical Trials Management Blog

Leading thoughts about the clinical research industry and the healthcare landscape.

Are you FDA Ready?

We all know clinical research is a highly regulated industry. Research involving people must be carefully planned and monitored to ensure risks are at a minimum and benefits are maximized. The FDA regularly visits organizations conducting research to review processes, data management, and regulations to evaluate whether the program is operating appropriately. Such an inspection can be nerve-wrecking especially for individuals or a team who has never faced the situation. GuideStar recommends conducting a mock audit to better understand what happens during an actual visit and to ensure your team is FDA Ready™.

Learn more about GuideStar’s FDA Ready offering here.