By Janine Del Vecchio, Insmed Incorporated
You may think that late-stage changes to a study are the exception and not the rule, but if you poll data managers, you’d probably find that last minute requests are the norm. You can almost anticipate you’ll face protocol changes and/or CRF design changes and just have to manage.
During our first study build with Veeva’s EDC there was a late-breaking shift in strategy. Our Phase II, early stage feasibility study in a new indication turned into the program-leading first trial. As we were finalizing the database build, the MDs recommended that we establish data collection standards for the new indication—starting with this first study.