
CRO was experienced but not proactive.
Date: May 1, 2014
Service Description
Toxicokinetic bioanalysis for GLP Tox study
What Went Well
The experience PPD has on TK/ADA analysis are big help to get the project going. The familiarity with regulatory guidance is reassuring.
What Could Be Improved
Communication with sponsor is not smooth. Don't have a clear plan but was driven by sponsor.
Lessons Learned from the Experience
It's a rather routine bioanalysis GLP support. However, PPD was not proactively take charge of in delivering the service, despite it has the capability and expertise to do so.