Service Description

Nonclinical safety studies from non-GLP target organ toxicity studies in rodents to GLP chronic toxicology studies in rodents and nonrodents

What Went Well

In general, the in-life portions of the toxicology studies conducted at the CRO went well. Recently, there have been mistakes due to negligence, such as some animals were not fasted before sampling for clinical pathology parameters while others were.

What Could Be Improved

The study reports almost always need major work to be comprehensible. It seems the study directors just cut/paste from each subreports to make the study report with no effort to try to tell a story. The scientific managers did not seem to have major input in the process. .

Lessons Learned from the Experience

We have repeatedly provided similar feedbacks to the CRO, without major changes. Recently, we started to put studies at other CROs.