Metabolic disease
Accelerate confident decisions from pre-clinical through post-marketing surveillance
We partner with sponsors to de-risk and accelerate metabolic studies via custom assays, logistics, and regulatory data across common and rare indications.
How we partner with you
-
Early collaboration to map biomarkers to mechanism, endpoints, and regulatory context
-
Operational design to optimize sampling windows, stability, and patient burden
-
Assay lifecycle management for multi-year, multi-center, global programs
-
Proactive risk management with contingency planning and redundancy
-
Transparent communication and dedicated program management
Bioanalytical & specialty testing
-
Ligand binding & immunoassays: insulin, C‑peptide, adipokines, cytokines/chemokines, inflammatory mediators
-
Genomic & molecular: RT-qPCR, qPCR/ddPCR for gene expression and copy number; NGS panels (as applicable)
-
Cell-based & functional: receptor/transport activity, mitochondrial function, oxidative stress readouts
-
PK/PD & immunogenicity: biologics, peptides, and small molecules with robust ISR and cut-point strategies
-
LC–MS/MS: quantitative analysis of targeted metabolic biomarkers across amino acid, acylcarnitine, lipid, and steroid pathways
Biomarker strategy & assay development
-
Biomarker consulting (mechanism-aligned selection, endpoint strategy)
-
Context of Use (COU) driving fit-for-purpose development, qualification and/or validation (small & large molecules)
-
Method transfers, bridging, cross-platform harmonization
Quality, compliance & governance
-
CLIA, GxP-compliant workflows with rigorous QA oversight
-
End-to-end documentation, change control, and deviation management
-
Submission-ready reports and data packages designed for global regulatory expectations
Speak with our metabolic experts
