Service Description

Covance was contracted to conduct GLP repeat ocular dose studies for up to 3 months in rabbits and dogs. The dosing included 4 times daily dose administration, toxicokinetic evaluations, and, in one study, bioanalytical work. Ophthalmology examinations were conducted by board-certified veterinary ophthalmologists.

What Went Well

Having worked with several Covance study directors, there is consistency on how the studies are handled, from initial contact to issuing a final report. In part, this may be because of the assigned study toxicologist, who has generally been the same person. Regardless, I know the product that I will be receiving. Covance is also very receptive to digging down to understand perhaps unexpected findings - especially with their histopathologists. In one case, some abnormal histological findings in the Harderian gland were further evaluated, including across other studies, to find out that the finding was related to a procedure and not test material (they presented a post on this at the SOT). In another case, an unexpected histological non-ocular finding was further evaluated - although the specific root cause was not identified, the findings was appropriately presented within the context of the study. I have multiple examples of the staff going the extra mile.

What Could Be Improved

Probably there are 2 areas that could have been improved (but have already improved since first working with Covance). The first is to take the initiative to understand unusual or unexpected findings - my general experience is that we, as the study sponsor, have had to ask for a further understanding. The second area has been with the report writing (although this has greatly improved). Like many another CROs, for the draft of the final report, the summaries from the contributing authors were cut and pasted, with no further integration. This has improved greatly.

Lessons Learned from the Experience

As we have worked with Covance for several studies, I don't know that there were any lessons that I learned by working with them again. As with any CRO, you do need to truly monitor the study progress and maintain open dialogue with the study director/study toxicologist. As a pharmaceutical-based CRO, a little more diligence in identifying outlying information would be helpful.