Service Description

We have approached Charles River Labs to conduct an oral non-GLP toxicokinetic study of of of our lead compounds in male and female Gottingen minipigs. The study was conducted in its entirety in Montreal, Canada with subsequent plasma/serum samples shipment back to us in PA.

What Went Well

We have had prior experience with Charles River Labs before including the conduct of numerous Pre-Clinical ADME and PK studies. Their broad capabilities and depth of knowledge were highly regarded such that we decided to conduct this current TK study with them again. The project timing was very punctual and with high quality results. Even though this was not a GLP-compliant study, the CRO was very thorough in their documentations and findings.

What Could Be Improved

Considering the fact that we have chosen Gottingen minipigs as the species of choice for this particular study, the CRO did not have/establish enough colonies available to start project right away.However, it did not take long for them to order the required number of both males and females to expedite the study. The fact that this was conducted outside of the USA (in Montreal, Canada) had occasional hiccups during samples shipments to/from the USA due to customs. This wasn't by any means the fault of the CRO, but would have been nice had they used or carried minipig species in the USA for such studies.

Lessons Learned from the Experience

For us, CRO reliability is of an utmost importance for continued collaborations. Charles River Labs have shown over and over again that their expertise in toxicology and safety pharmacology goes beyond what other service provides have to offer. Deliverable were on time and their scientific staff were readily available to discuss and elaborate any concerns we had throughout the study. I have no dought that we'll consider them again for the GLP phase of this study in the near future.