I have a relatively new client in China for whom we are starting to plan for GLP studies in that country. They previously conducted DRF studies prior to my entry. When I indicated that I should be the Study Monitor, the Sponsor responded as follows:
It is almost impossible for you to directly direct or monitor the study due to the language barrier /or geographic distance/time zone challenges. To effectively use your knowledge and experience, it would be more productive that you serve as a reviewer and advisor to the team for study design, protocol development, execution of the study and interpretation of results (report). We will work with the lab in implementing the studies to the words per study protocol approved.
I am generally not in agreement with this philosophy. The idea of the client’s team (who are not toxicologists) working with the lab in implementing the studies, but having me as a reviewer/advisor, will ultimately be problematic as regulatory agencies will not exactly see it that way. It will be like having responsibility without authority.
I am therefore interested in hearing comments from RTC members, especially those who place/monitor studies in Chinese CROs, before I provide a response to the client. Thanks in advance.
Barry S. Levine, DSc
Diplomate, American Board of Toxicology
Levine Tox Consulting, LLC
Consultants in Toxicology
and Nonclinical Development
2440 N. Lakeview Ave.
Chicago, IL 60614
Tel (773) 697-4846
Fax (312) 546-6334
Cell (312) 550-0100