Enhancing Pharmacokinetics Workflows at Charles River

Charles River, a global leader in drug development, sought to improve its pharmacokinetics (PK) analysis across its seven worldwide sites. With each site using its own systems, workflows, and procedures, the company recognized the opportunity to optimize consistency in PK analysis and reporting. By centralizing efforts and refining processes, Charles River aimed to enhance scientific methodologies, improve data handling practices, and ensure continued adherence to the highest standards of regulatory compliance.

The company’s existing systems were becoming less efficient and lacked seamless integration. With multiple versions of Certara’s Phoenix platform in use, documenting compliance with 21 CFR Part 11 was becoming time-consuming. Additionally, the absence of a unified and secure repository for PK data led to teams spending excessive time searching for data and demonstrating compliant data provenance – time better spent on the precise and well-contextualized analysis on which Charles River has built its reputation

They required a solution that could ensure uniformity across all sites, while maintaining the flexibility to handle varied client demands, complex study designs, and different regulatory frameworks such as FDA requirements in the U.S. and OECD guidelines in Europe.

Charles River relies on Phoenix as its core analytical tool for generating PK parameters. With this Phoenix, teams standardized their reporting methods, ensuring that all global sites provided the same high-quality, compliant output.

By pulling data directly from Phoenix and other software into the secure, cloud-based repository Integral, Charles River eliminated inefficiencies and ensured data integrity. Integral serves as the central data repository for PK information, providing scalable storage and ensuring compliance with data security regulations.

PKAssist¹, a customized tool developed in collaboration with Certara, replaced the cumbersome, manual workflows with a more automated, efficient system. This tool proved especially helpful in automating the generation of SEND datasets, ensuring that non-clinical data was processed and analyzed consistently across all global sites.

The result is a single, secure global PK database at Charles River that ensures regulatory compliance for both production and computer systems, while guaranteeing data integrity and change control. This enables the company to implement more secure, compliant, and efficient workflows.

Throughout the implementation, the collaboration with Certara played a pivotal role. They provided ongoing support, not just during the initial setup and deployment, but also throughout production, ensuring that the system continued to meet Charles River’s evolving needs.