Best Practices For Clinical Trial Labeling Success

By Joanne Staszczyszyn, Project Manager, Clinical Services and Kay Kim, Label Coordinator, Clinical Services

We know it’s your priority to get your clinical trial in the hands of your patients — wherever they may be.  And, it’s no small task. From site selection and patient enrollment to managing regulatory approval and ensuring the integrity of your trial data, your role is critical to the success of the study. If you are also responsible for the labeling of your trial drug you know that this is sometimes an afterthought or considered the final phase in the process, however, it is the key to the overall success of the trial.

A focus on pre-planning and following labeling best practices, will not only help you get your trial drug ready faster, but will ensure all regulatory requirements have been met and prevent any delays in study start-up.