Service Description

Operations Support for Phase II Adaptive Trial Statistical analysis and support for the adaptive Trial Help with Site Selection

What Went Well

Vendor used the EAST software for statistical work The quality of the work was high The work was delivered on time to meet tight deadline

What Could Be Improved

Could have provided better graphical representation of the statistical information Made it a bit less technical for clinical audience Overall happy with the work

Lessons Learned from the Experience

Yes it was outside the box biomarkers incorporated in to adaptive thinking Learnt the idea of adapting the trial based on predictive biomarkers