ABSTRACT
Your study report is only as good as the supporting data. If you do not exercise due
diligence in qualifying a Contract Research Organization (CRO) before placing your
study, you might face business and regulatory risks later. It is important to ensure that
systems are in place at the CRO that guarantee the integrity of your data and regulatory
compliance of the study with Good Laboratory Practice (GLP) Regulations (1). The study
report is the product of your scientific efforts and labor. If the report is not accurate,
complete, and substantiated by the raw data, the conduct of a nonclinical study is of no real
value to the sponsor or the U.S. Food and Drug Administration (FDA). Often the health
and safety of the general public may well depend upon the results of a single toxicology
safety study.
