Service Description

Although it is a quite standard study, there were several issues: 1) we had performed previously a preliminary study with another CRO in a different country and for changes in local laws we were forced to perform part of the full GLP-compliant study with a new CRO 2) The indication by Regulatory Authorities was to use in the new study (at Covance) the same parameters of the preliminary study. 3) it was a three center study: one for toxicology (except Pathology), i.e. Covance, one for pathology and one for toxicokinetics.

What Went Well

The preparation of protocol was a difficult step as three centers/CROs were involved. Furthermore, we were obliged to follow the parameters (animal strain and treatment, diet, experimental observations etc.) used in the preliminary study performed by a different CRO in another country, instead of the standard parameters in use at Covance. Covance was really proactive in adapting their standard to our requirements. As the Sponsor Study Monitor, I received an e-mail from the Study Director at Covance daily during the protocol preparation and at least three times per week during the study start and first month. This was very reassuring for us regarding the quality of the work that Covance was doing.

What Could Be Improved

In my experience one aspect that may be improved is how to deal with a non-programmed absence of the Study Director. When it happened, just before the start of the study, we had to send again some documents &information that Covance already received from us. It appears that some pieces of information remain in a "personal" archive of the Study Director.

Lessons Learned from the Experience

It was a bit hard at the beginning to make Covance deviate from their standard procedures. However, the Study Director at Covance did an excellent job in harmonizing their procedures with our requests. Also, the Pathology site for the study (in a different CRO) made very helpful discussions with Covance pathologists. We did not need in this case "innovative" proposals but a flexible approach. And at the end they give us exactly that. We also visited their site and our feedback is really positive.