Service Description

Covance was contracted to conduct preclinical GLP studies. The program involved studies in a rodent and a non-rodent species including acute and chronic oral dosing. In addition, the program involved several in vitro pharmacology and toxicology studies.

What Went Well

Covance was instrumental in the design of the studies and providing input on potential alternatives and with guidance on additional studies that could be conducted to help interpret findings from initial studies. They were also familiar with regulatory requirements and were able to bring to bear internal expertise. They were also fairly responsive to our needs with regards to initial timelines.

What Could Be Improved

Covance is a well-established lab with well-established procedures and processes and does an excellent job for all the standard nonclinical studies particularly when things go according to plan. It is harder to get things done when the program requires some unique approaches given the pharmacology of a compound or procedures required. It is also a large organization so there is also a tendency to be less accommodative and less flexibility in how studies are conducted or placed, and in completing reports.

Lessons Learned from the Experience

Covance is very good at conducting studies that conform to standard norms and requirements. There is less flexibility for "outside the box" thinking or studies that require these approaches. It is also harder to negotiate or leverage, especially for smaller organizations. To balance this, they are able to provide expertise in all therapeutic areas and can bring to bear their resources in a crunch and for companies that may not have a large in house staff, they can provide all the services and resources to successfully meet regulatory requirements.