Service Description

The CRO has been contracted to run routine samples. The CRO also is responsible for supporting several active stability programs. Finally, the CRO is responsible for validating several assays prior to process validation runs.

What Went Well

The CRO did a great job of running a complex assay and generating suitable results to allow us to adjust our process accordingly. The CRO did a good job flexing resources as required by our projects shifting time lines. Finally, the CRO did a good job of meeting timelines for all of our projects currently at the facility.

What Could Be Improved

More flexibility would be ideal for the customer. Another thing that could be improved would be scope of the technologies currently available within the CRO. It would be nice for there to be more contact between our SMEs and the SMEs at the CRO.

Lessons Learned from the Experience

This CRO is a top quality partner. We have worked with several other CROs on similar projects and their data quality and ability to meet our timelines did not match what we get at the CRO being discussed. They are very creative with managing activities to meet deliverables.