Service Description

PPD was contracted to recruit subjects for a Phase I study. This was a multiple rising dose study in healthy volunteers. We contracted the enrollment of subjects and their on-site laboratory.

What Went Well

PPD followed the assessments and performance of the assessments perfectly. The contract with PPD was a reasonable cost. The quality of the staff is very high and very responsive and thorough.

What Could Be Improved

PPD was unable to recruit all the subjects that were needed for the second half of the study. The protocol was written for 2 cohorts of 8 subjects each to be enrolled in parallel. PPD fell short by 2 subjects. In addition, one subject withdrew from the study. PPD was only able to fill 2 of the last 3 slots. This also resulted in a timeline delay.

Lessons Learned from the Experience

The lesson learned is that being too aggressive does not always pay off. Since we were short the first time in recruiting the necessary subjects, PPD should have realized that recruitment may be a problem and suggested an approach to bolster recruitment. Overall, PPD is an excellent CRO, but this study ended in a bit of disappointment.