Service Description

Phase 1, crossover, BA/BE study in healthy subjects under fasting conditions

What Went Well

They are able to accommodate the last minute change on the dosing date they are able to recruit 30 subject within 2 weeks.

What Could Be Improved

Under staffs during the study. Because of this, lots of protocol deviations for the study.

Lessons Learned from the Experience

Because of the last minute change of the dosing date they end up with under staffed during the study. They may run multiple studies from different sponsors at the same time. And they may not be capable to do that.