Last-Minute FDA Updates Threatening Your Go-Live Date? Tips For Staying On Track

The final days before First-Patient-In (FPI) on a global trial are normally hectic, but when last-minute changes are required by regulators, there’s typically little to no hope of meeting the start date. 

System specifications shared during the requirements gathering phase are usually no problem for developers. However, when those same specifications are shared just days before the study “go-live” date for a global trial conducted in multiple languages, they can present an enormous challenge for everyone.