Medpace Biomarker Services
Medpace integrates biomarker strategy with laboratory and clinical execution to deliver reliable data and accelerate development timelines.
Medpace integrates biomarker strategy with laboratory and clinical execution to deliver reliable data and accelerate development timelines.
Integrated Biomarker Strategies for Clinical Development
Biomarkers are central to modern clinical development – guiding patient selection, demonstrating pharmacologic activity, and enabling earlier, more confident decisions. Medpace integrates biomarker strategy, laboratory execution, and clinical operations within a single, aligned team – ensuring consistency, quality, and delivery across every phase of development.
Medpace biomarker teams operate within a mature clinical trial infrastructure – providing direct access to global logistics, sample management, data operations, project management, and clinical trial teams. This integrated model supports both scientific rigor and operational responsiveness throughout study execution.
Why Use Medpace for Biomarkers?
Successful biomarker implementation requires more than scientific expertise alone. It demands coordination across study design, assay development, sample logistics, and clinical execution. Medpace delivers this through a fully integrated model – connecting biomarker science directly to trial delivery.
Whether supporting early-phase pharmacodynamic endpoints or large global trials requiring highly standardized biomarker testing, our teams work together to ensure biomarker data is reliable, actionable, and delivered on time across our sites in the US, Europe and Asia-Pacific.
Biomarker Expertise Across Laboratories
Medpace supports biomarker strategies through our integrated central laboratories and bioanalytical laboratory, providing the scientific expertise, operational infrastructure, and validated testing platforms required throughout clinical development. Our capabilities include:
- Cell-Based Biomarkers & Flow Cytometry: Immune monitoring, characterization of immune cell populations, protein expression, receptor occupancy, target engagement, cellular function, and immunophenotyping to support immunology, oncology, and cell therapy programs.
- Molecular & Genomic Biomarkers: DNA, cfDNA and RNA analysis, genomics, transcriptomics and molecular testing to support patient stratification, disease characterization and monitoring, and precision medicine approaches.
- Soluble Biomarkers & Cytokine Profiling: High sensitivity singleplex and multiplex immunoassays, ligand binding assays, and cytokine analysis supporting pharmacodynamic assessment, safety monitoring, and biomarker endpoint evaluation.
- Tissue-Based Biomarkers & Anatomic Pathology: Anatomic pathology, histology, immunohistochemistry, fluorescence microscopy, and tissue characterization to support translational and clinical development objectives.
- Bioanalytical Biomarkers & PK/PD Assessment: Mass spectrometry, ligand binding assays, and integrated PK/PD testing to evaluate exposure-response relationships, mechanism of action, and dose optimization.
- Biomarker Assay Development, Validation & Method Transfer: Development, qualification, validation, and transfer of biomarker assays within GLP, GCP, and CLIA environments to support clinical and regulatory requirements across study phases.
