Service Description

The CRO was provided the opportunity to perform virtually the entire range of IND enabling preclinical safety tests for a new molecular entity

What Went Well

The CRO was initially very easy to work with, schedules were laid out, the timelines were tight but not impossible. Once testing began the work initially progressed as expected. Non- doctoral levels project management were pleasant and earnest.

What Could Be Improved

The preclinical studies were not properly supervised by knowledgeable Veterinarians and clinical interpretations were made without considering underlying pathophysiologic data. Weeks of frustrating discussions were then necessary. In short if the vets called into the animal rooms understood the PK/PD of the drug candidate prior to "their shoot from the hip diagnoses" we'd of been much happier with them.....

Lessons Learned from the Experience

We will seriously question the wisdom of working with a CRO that has so many layers between scientific / clinical management and the folks that actually do the work. There was not enough thinking in the box much less thinking out of the box. They did nothing to solve a well established problem but added to them.....