
Covance is very regulated and well organized, but not possible to work out of the box with them
Date: May 2, 2014
Service Description
Covance was the central lab for the study. Beside this Covance was asked to validate some ELISA based test. Covance worked as a central lab in one of the studies. Thus all logistic of sample shipment was organized by Covance. Also sample reconciliation and storage was done by Covance. In addition Covance was asked to set up some ELISA based measurements. Thex did some validation work and measured the samples of the clinical study.
What Went Well
The communication was most of the time good (e.g. if we had issues and contacted Covance always responsible people were reachable). Covance was very responsive and always willing to solve issues quickly. The whole work of Covance is very regulated and well organized. They have for all aspects guidelines and SOPs.
What Could Be Improved
We had high rate of exchange in people. It would be better if people stay longer on the same study. Their regulated environments makes it sometimes difficult to act on issues flexible. Shipping works for example according to special plans. Thereby it happens that they had 4 shipments on dry ice in one week. Here they should have only one. This happened throughout the study and raised the cost immensely. Fir discussions of new projects they sometimes incl. people from all over the world which makes it complicated.
Lessons Learned from the Experience
Single people try to think out the box. However, due to the very regulated way Covance work it is not possible to work out of the box with them. We had several small issues, where Covance could not help because of their guidelines. Here we had to involve other companies. Examples are e.g. providing special buffer for biomarker assays, Change of labels,....I learned that they pay the highly regulated work they do (which is most of the time good) with having no flexibility which is (especially during phase I) also important.