Advance Regulatory Confidence Through Virtual Control Groups

Adoption of Virtual Control Groups

In an environment of increasing regulatory scrutiny and scientific complexity, confidence is built on more than compliance; it is built on evidence. Charles River’s newly published peer‑reviewed article, Virtual Control Groups in Nonclinical Research: A Re-analysis of 20 Studies Using Virtual Control Group Data, appearing in Regulatory Toxicology and Pharmacology, reinforces our commitment to advancing the science that underpins sound regulatory decision‑making and successful adoption of (VCGs) in toxicology settings.

Featured in one of the field’s most respected journals, this research reflects the depth of expertise Charles River scientists bring to safety assessment, toxicology interpretation, and regulatory strategy. Featured in one of the field’s most respected journals, this research reflects the depth of expertise Charles River scientists bring to safety assessment, toxicology interpretation, and regulatory strategy. More importantly, it demonstrates how rigorous, data‑driven science can translate into clearer insights, reduced uncertainty, and stronger regulatory confidence for sponsors looking to adopt New Approach Methodologies (NAMs) into their future programs.

Why do VCGs Matter?

• Rising Regulatory Expectations: Across pharmaceuticals, biologics, and emerging modalities, regulatory agencies are increasing expectations for how safety data are generated, interpreted, and scientifically justified, with a strong focus on NAMs and the 3Rs. Drafts are being developed for VCGs as they support non-GLP dose-range finding studies through the latest announcements shared by the EMA
• Growing Sponsor Challenges: Sponsors are increasingly challenged to contextualize findings, address variability, and support conclusions with robust scientific rationale
• Directly Addressing the Gap: This research directly responds to these challenges through a disciplined methodology and regulatory‑relevant analysis
• Improved Toxicological Consistency: The study provides practical insights that enhance consistency and clarity in toxicological evaluation
• Broad Development and Regulatory Impact: While grounded in technical expertise, the implications are broad, supporting more informed decision‑making throughout development and across regulatory interactions

Explore VCGs

From Execution to Scientific Leadership

Charles River’s role extends well beyond study execution. Our scientists actively shape the field through research, publications, and collaboration, ensuring that lessons learned across decades of work inform both current and future programs.

The virtual control group and concurrent control group research outlined in this article draws on deep institutional knowledge, including extensive historical control data and experience across a wide range of compounds and therapeutic areas.

Driving Innovation with Virtual Control Groups
Virtual control groups reduce animal use and improve toxicology studies with data driven, AI enhanced methods that strengthen safety assessments.
Discover the benefits

A Continued Commitment to Progress – VCGs and NAMs

As innovation accelerates and development of NAMs and Concurrent Control Groups (CCGs) models evolve, Charles River remains committed to advancing the scientific standards that enable safe, efficient progress. This latest article is one example of how Charles River continues to invest in science that matters: science that informs decisions, reduces risk, and ultimately helps bring safe and effective products to market.

Have VGC Questions?