Enhancing Pharmacokinetics Workflows at Charles River

Charles River operated seven worldwide sites with disparate systems and workflows for pharmacokinetics analysis, running multiple versions of the Phoenix platform without a unified, secure data repository; teams spent excessive time locating data and documenting 21 CFR Part 11 compliance while still needing flexibility for varied client and regulatory demands. Charles River deployed a global integrated platform combining three Certara components: Phoenix for standardized PK parameter generation, Integral as a cloud-based centralized data repository, and PKAssist for automated SEND dataset generation. This harmonized PK analysis and reporting across all sites, enabled real-time data access from anywhere, and improved efficiency, regulatory compliance, and data integrity/change control; future plans include cloud migration, REST API integrations, and AI applications. No specific numeric outcome metrics are given.

Certara is a biosimulation software company (Simcyp, Phoenix) whose PK/PD and QSP models predict drug behavior in the body; the FDA itself licenses Certara's software to review sponsor submissions.

This sits in the Build stage of the AI use-case lifecycle: Named examples from the foundation-model labs and platforms pharma teams use to actually construct, train and generate the model or application.