You’ve built your study and collected your data, and now it’s time for database lock. Congratulations! This is no easy task - any number of unforeseen setbacks can arise during a clinical trial, from patient attrition to misplaced source data and beyond - so don’t be afraid to enjoy the moment.
Now comes the moment of truth: FDA submission. Even if your site staff and data managers do everything right during your trial, it’s ultimately the FDA who will decide whether your product moves on to the next clinical phase. What can you do during your study to maximize your chances of success when it comes time to submit?