As your dedicated central laboratory, our results may comprise the majority of all data submitted in a NDA. We fully understand the necessity and importance of harmonizing our laboratory facility operations to ensure that all results generated via any of our laboratories around the world can be easily and seamlessly combined.
Utilization of global standard operating procedures, uniform instruments, reagents and analytical methods for safety testing enable the use of global reference ranges, resulting in uniform laboratory data that is completely combinable.
We put in every effort to secure the highest level of standardization by managing our central safety laboratory operations in the United States, Europe, Singapore, and China in the most appropriate and efficient way. Our high level of standardization removes all hurdles associated with collecting and integrating laboratory data versus local laboratories with low or no level of standardization, using different methodologies, reference ranges and or operating procedures.