Covance Review: Phase 1 PK bridging study

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210 Carnegie Center
Princeton, NJ 8540
United States
(888) 268-2623

Phase 1 PK bridging study

Overall: 4 stars

Date: April 11, 2015

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Service Description

The study that was outsourced to Covance was a PK bridging study. It was designed to compare the PK of two different clinical drug products of the same NCE. One formulation had been used in a proof of concept study and the other was developed as a commercial product. Covance phase 1 unit was selected to conduct this phase 1 study.

What Went Well

Covance was very proactive in the pre-trial stage. We were provided cost estimates for different options under our considerations. We were also able to get the principle investigator designated to this study very early on and get him involved in study design and conduct discussions very early. The site staff team were very approachable and responsive. During the study, the site team always reported their observations, especially any unusual ones, at their earliest to the sponsor. They were knowledgable, responsible and reliable.

What Could Be Improved

We did not encounter any major issues. There was one personnel change during the study and caused a little bit confusion in communication. However, once this issue was pointed out to the site, Covance got their management involved immediately and the issue was resolved in no time. We were satisfied with the results and understand sometime this is unavoidable. What matters is that they have a very efficient process in place to achieve a good resolution in the most efficient manner.

Lessons Learned from the Experience

The Covance team always tried their best to provide relevant inputs to us based on our needs. I would say they did think outside the box when needed. We also gave them the opportunity to express their ideas with us. It is the best to integrate the two study teams, one from the sponsor and one from the CRO to work together as one super team at some levels to achieve the best.