Service Description

PPD was contracted to design, optimize and validate a multiplex LC-MS assay to be used as a PD biomarker in phase 1 and phase 2 clinical studies. They were also contracted to measure the PD biomarkers in clinical samples from these studies.

What Went Well

The assay was successfully developed. Problems were identified and solved. The assay is currently in use in our clinical trials.

What Could Be Improved

The CRO slipped significantly on the timeline -- by many months. THe reason given for the setbacks and delays was "we have other projects that are more important." Overall, the communication was not optimal.

Lessons Learned from the Experience

We solved the problem by setting up regular meeting to monitor progress and track timelines and deliverables. I learned that this CRO requires close management. I also worked to imporive the relationship between my company and the CRO. Several contracts were being negotiated and the general tone of those conversations may have had a negative impact on the laboratory team. The CRO did bring technical expertise and experience in troubleshooting, and I would work with them again but with closer management.