Charles River Highlights Effectiveness of VCGs in Toxicology

Key Terms

virtual control groups technical

Virtual control groups are comparison groups created from existing patient data—such as past trials, electronic health records, or registries—rather than by enrolling new participants into a placebo or standard-care arm. For investors, they can shorten timelines, cut trial costs and reduce the number of people needed in a study, but their value hinges on the quality and regulatory acceptance of the underlying data, which can materially affect approval risk and commercial timing.

concurrent control groups technical

Concurrent control groups are sets of trial participants who receive a placebo or standard care at the same time and under the same conditions as the group getting the experimental treatment. Having controls run concurrently with the treated group helps ensure differences in outcomes are due to the treatment and not to changing conditions, like shifts in patient mix or care practices; for investors, this increases confidence in trial results and the likelihood regulators will view the data as reliable.

no observed adverse effect level medical

No observed adverse effect level (NOAEL) is the highest dose of a drug or chemical in a safety study that produces no detectable harmful effects on test subjects; think of it like the strongest amount you can take of a product without seeing negative effects in testing. Investors watch NOAEL because regulators use it to set safe exposure limits and guide human dosing decisions, so a clear, favorable NOAEL can reduce regulatory risk and help a development program stay on track.

ai-enabled analytics technical

AI-enabled analytics are computer tools that use artificial intelligence to sift through large amounts of data, spot patterns, make predictions and present insights in a clear way—like a smart assistant that quickly sorts and highlights the most important items in a crowded inbox. For investors this matters because it can speed decision-making, reveal risks or opportunities that humans might miss, and potentially improve forecasting, efficiency and competitive advantage.

dose-range finding medical

An early-stage study that tests several dose levels of a drug or treatment to find the range that is both safe and likely to work. Think of it as trying different amounts of an ingredient in a recipe to see which gives good flavor without causing problems; for investors it shapes the risk and timeline of development by identifying safe doses, guiding later trials, and indicating the potential for regulatory approval and market use.

non-glp regulatory

Non-GLP describes laboratory studies or tests conducted without following formal government-quality and documentation standards called Good Laboratory Practice. For investors, non-GLP results can still show early promise—think of a rough prototype or internal check—but they carry more uncertainty and usually won’t be accepted by regulators as definitive evidence, so they require confirmatory, GLP-compliant work before being relied on for approvals or major financial decisions.

new alternative methods technical

New alternative methods are recently developed ways of doing tests, measurements or procedures that replace, reduce or supplement traditional approaches—often used in scientific research, product testing or regulatory compliance. They matter to investors because these methods can cut costs, speed up product development, lower regulatory risk and open new markets; think of switching from a slow manual assembly line to a faster, cheaper automated system that improves output and reduces uncertainty.

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Peer-reviewed evidence supports the use of Virtual Control Groups in nonclinical toxicology studies

WILMINGTON, Mass.--(BUSINESS WIRE)-- Charles River Laboratories International, Inc. (NYSE: CRL) has shared the results of a retrospective analysis in Regulatory Toxicology and Pharmacology, showing that virtual control groups (VCGs) can preserve scientific integrity while reducing reliance on animal models. The review, which looked at 20 toxicology studies that replaced concurrent control groups (CCGs) with curated VCGs, and compared the outcomes across study-level decisions and detailed endpoints. There was 100 percent concordance in the No Observed Adverse Effect Level (NOAEL) across all studies, and although there was some minor endpoint-level variability between the CCG and VCG, the core study conclusions remained unchanged. Continued research with clients has been ongoing to enhance and refine models to address these variabilities. Charles River’s VCG program is guided by the Alternative Methods Advancement Project™ (AMAP), an initiative focused on reducing the use of animals in research where scientifically appropriate.

“Virtual Control Groups show that scientific rigor and meaningful reductions in animal use are not mutually exclusive,” said Dr. Namandjé N. Bumpus, Chief Science and Innovation Officer, Charles River. “By combining decades of curated historical data with advanced analytics, VCGs allow us to reduce animal use while preserving the highest commitment to scientific validity. This work demonstrates what’s possible when innovation, ethics, and industry collaboration move forward together, and it opens the door to a more predictive and efficient future for safety assessment and reduced reliance on animal use in research.”

Impact of VCGs
VCGs apply historical control data, advanced statistics, and AI-enabled analytics to digitally replace a portion of concurrent control animals in regulated safety studies. By reducing animal use and improving data interpretability, VCGs offer a modern, ethical, and scientifically robust alternative for developers seeking more efficient decision-making.

“Our focus has been on translating VCGs from concept to execution,” added Laura Lotfi, Director of Digital Products at Charles River. “Working side by side with our clients, pathologists, toxicologists, and regulators, we are demonstrating how these data-driven approaches can enhance study efficiency, strengthen interpretation, and deliver regulatory-ready results in real programs today. VCGs are no longer a question of feasibility, but of defining when and how they can be optimally implemented.”

Virtual Control Groups help accelerate timelines, enhance data quality, and meet evolving regulatory expectations for the 3Rs (replacement, reduction, refinement).

• Up to 25% reduction in control group 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
• Improved study efficiency, freeing resources and enabling teams to focus on higher-value scientific questions

Charles River brings deep toxicology expertise and a long-standing commitment to alternative methods, highlighted through the formation of their Scientific Advisory Board, a global, cross-functional team focused on accelerating adoption and validation of New Alternative Methods (NAMs.)

Global Industry Collaboration
In 2025, Charles River joined the VICT3R Project, a public-private consortium funded by the Innovative Health Initiative (IHI), to help bring VCGs into mainstream toxicology. The VICT3R Project aims to modernize nonclinical safety assessment by building a comprehensive, global database and creating the frameworks required for future adoption of virtual control groups across the industry.

This type of industry collaboration led to the European Medicines Agency’s recent draft qualification, focusing on the application of VCGs in dose-range finding (DRF) non-GLP repeated dose toxicity rat studies. This is an important step towards the regulatory acceptance of VCGs.

“Collaborating with the regulatory agencies is crucial as we progress validation work in alternatives like VCGs,” added Bumpus. “Partnering to design qualification standards for data-sets and define acceptable use cases early on will help build the industry’s confidence in VCGs and support their adoption once they are validated alternatives.”

Charles River remains committed to advancing the validation and acceptance of NAMs. Together with clients, regulators, and the industry, NAMs provide a foundation for a future where more patients gain access to life-saving treatments—safely, swiftly, and with reduced reliance on animal use in research where scientifically appropriate.

About the Alternative Methods Advancement Project (AMAP)
The Alternative Methods Advancement Project (AMAP) is a Charles River-led initiative dedicated to developing New Approach Methodologies (NAMs) and exploring innovative scientific and technological solutions aimed at reducing reliance on traditional animal testing. As we enter the next frontier of drug development, AMAP™ enables strategic, purpose-driven investment to shape a future in which more patients can access the treatments and medicines they need safely, swiftly, and successfully. AMAP is supported by our global, cross-functional Scientific Advisory Board led by Dr. Namandjé N. Bumpus.

About Charles River
Charles River provides essential products and services to help pharmaceutical and biotechnology companies, government agencies and leading academic institutions around the globe accelerate their research and drug development efforts. Our dedicated employees are focused on providing clients with exactly what they need to improve and expedite the discovery, early-stage development and safe manufacture of new therapies for the patients who need them. To learn more about our unique portfolio and breadth of services, visit www.criver.com.

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Charles River Investor Contact:
Todd Spencer
Corporate Vice President,
Investor Relations
781.222.6455
todd.spencer@crl.com

Charles River Media Contact:
Amy Cianciaruso
Corporate Senior Vice President,
Chief Communications Officer
781.222.6168
amy.cianciaruso@crl.com

Source: Charles River Laboratories International, Inc.