Translational Evidence Framework for Human-Relevant NAM Validation

CER Groupe is a non-profit Belgian collective research centre dedicated to advancing human and animal health through integrated research, analytical services, and translational preclinical expertise. With nearly 50 years of experience and a multidisciplinary infrastructure under one roof, we support the development, validation, and adoption of innovative biomedical technologies.

Within the context of New Approach Methodologies (NAMs), CER Groupe positions itself as a translational validation partner, ensuring that human-relevant in vitro and ex vivo models are supported by robust biological evidence, high-quality analytics, and regulatory-ready datasets. Our role is to bridge experimental innovation with measurable, reproducible outcomes that increase confidence for industrial, clinical, and regulatory stakeholders.

What we can contribute

CER Groupe provides integrated translational validation to strengthen the robustness and credibility of human-relevant NAMs. Our contribution focuses on:

-            Cross-validated experimental strategies linking in vitro models to disease-relevant in vivo readouts

-            Advanced analytical, immunomonitoring, and biomarker capabilities supporting mechanistic interpretation

-            Standardised sample handling and biobanking ensuring data quality, traceability, and regulatory readiness

This integrated approach helps consortia move from innovative models to reproducible, measurable biological evidence.

Partner interest

CER Groupe seeks to complement consortia developing human-relevant NAM platforms by collaborating with partners that reinforce regulatory acceptance, clinical relevance, and technological integration.

We are particularly interested in working with:

-            Regulatory and regulatory-science actors to support validation strategies and context-of-use definition

-            Clinical centres, hospitals, and biobanks providing access to well-characterised human samples

-            Technology providers and SMEs active in biosensors, organ-on-chip, microfluidics, or real-time monitoring

-            Data and AI partners enabling multimodal data integration and traceable interpretation

Together, these complementarities help ensure NAM technologies evolve into robust, regulator-ready solutions aligned with Horizon Europe expectations.