Service Description

The CRO was contracted to conduct a combined PK/PD and toxicity in nonhuman primates, including assessment of PD endpoints

What Went Well

The CRO qualified the PD assay in the agreed timeframe. During the pre-study phase there was good communication and all went according to plan.

What Could Be Improved

The main challenge proved to be delivery of key study data in the agreed timeframe - ie the timeframe previously explicitly agreed with the CRO on data delivery. It was disappointing this had to be renegotiated whilst the study was ongoing. This delayed the delivery of some outcomes to the project team, and obviously we had not anticipated these delays would occur, and this put us in an awkward position.

Lessons Learned from the Experience

The CRO in all fairness did do a reasonable job of delivering the data and discussed with us what to prioritize. What this has taught us is that it is probably worthwhile sitting down with the CRO business development and potential study manager ahead of awarding the study to gain confidence in whether or not study timelines can be met.