Service Description

The first study was to determine the MTD in juvenile rats, and the next studies were to determine the toxicity, toxicokinetics and respiratory safety in juvenile animals.

What Went Well

We have conducted many studies at the site, so they was a lot of familiarity with the personnel and capabilities. There were no difficulties in getting the studies scheduled and getting the resources to initiate the studies. The protocols were approved with not too much effort.

What Could Be Improved

The CRO was terrible in communication. We often had to prompt them for an update, only to get an e-mail notification that they were out of the office. The draft reports were terribly written, and some of the QA'd data had major errors. There were several protocol deviations that were either not discussed, or not properly investigated.

Lessons Learned from the Experience

The CRO had a flyer describing data they obtained in a juvenile rat study, yet we were forced to pay for feasibility because they didn't know where the data in the flyer came from. Even if the data was generated at another site (probably UK), there was very little to no intrasite communication. We experienced the same thing in a previous study at CRL, where a method was validated at one CRL site, and we tried to use it at another CRL site. The two sites wouldn't talk to each other, and they wanted us to pay for a validation again. They felt that they were meeting their timelines, but the reports were so deficient, they needed major work. For instance, in one study, the initial summary stated that there were no significant changes; however, if one were to look at the tables, there were about 2 dozen changes that were marked as being significant. We ended up putting this data into a table for them. On the analytical side, there were averages reported that were either higher or lower than any value being averaged. There was drug reported in placebo animals (an area for many FDA 483s), and this was not properly addressed. We had a very difficult time in making sure that we could get the reports finalized in order to file with regulatory agencies. We had a very tight time commitment, since these were post-approval studies. I had to contact senior management in order to meet our timelines, and there was a lot of effort on our part to get the reports in good shape. The reports that we have from other CROs have been much more thorough, and were written very well.