Charles River Laboratories' Virtual Control Group Database And Methodology To Be Used In An Upcoming Good Laboratory Practice-Compliant Study For Ipsen

This collaboration highlights Charles River’s and Ipsen’s dedication and commitment to championing the 3Rs (Replacement, Reduction, and Refinement of animal use in research) while upholding the highest scientific standards. Charles River’s VCG program operates under the Alternative Methods Advancement Project™ (AMAP™), an initiative aimed at minimizing animal use in research whenever scientifically appropriate.

By combining toxicology and regulatory expertise, historical control data, advanced statistical methods, and AI-powered analytics, VCGs can digitally replace a portion of concurrent control animals in safety studies. This approach lessens reliance on animal use while enhancing data clarity, offering a modern, ethical, and scientifically robust solution for developers seeking efficient decision-making. Charles River will supply VCG data to Ipsen to facilitate prospective analysis of general toxicology endpoints.

Advancing Virtual Control Groups

Virtual Control Groups may be able to impact study timelines, enhance data quality, and meet evolving regulatory expectations for the 3Rs.

Up to 12% reduction in animal use where scientifically appropriate, without compromising regulatory-grade rigor
Greater statistical power, particularly for detecting rare spontaneous findings that may otherwise obscure study outcomes
More consistent interpretation, leveraging large, curated historical datasets to contextualize unexpected results
As Charles River continues to advance innovative approaches through AMAP, collaborations like this demonstrate how science, technology, and expertise can work together to reduce animal use while maintaining the rigorous standards required to bring new therapies to patients.