Service Description

The CRO was contracted to perform a dermal study in minipigs to evaluate the systemic toxicity of a combination drug; study design included standard assessments for toxicity and TK

What Went Well

The execution of the study went overall well. Two monitoring visits were made, at the beginning and end of in life. Housing of the animals was appropriate, and in-life technicians showed good level of skill. Animals developed skin irritation and this was properly tracked by the personnel and discussed with Study Director which had experience in the model. Necropsy was well organized and staff showed knowledge of the procedures; I had one prosector walk me through the list of tissues collected. I was satisfied with the service.

What Could Be Improved

Initially noted that new Provantis system was not tracking/calculating dose volume. The CRO corrected this by using their old tracking system for dosing and Provantis for in-life data capture. Data updates were provided on a timely manner although there were comments on the data. I had to assume that no comments meant that the study was progressing well. I have conducted other studies in the same test facility and received a high level data overview before. There were no issues with delivery of the study.

Lessons Learned from the Experience

Important to monitor studies at beginning of in-life - systems/methods may change (e.g. Provantis) which is not very user-friendly for dermal studies and requires customization. CRO delivered in execution of study. This was a standard study without issues arising so we were not required to think "outside the box" but CRO showed experience in animal model and drug class.