CRO specialized in drug discovery, R&D, preclinical and clinical services
 

Biomarker Development and Validation Services

Biomarkers are now central to the advancement of precision medicine, particularly in oncology. They enable a deeper understanding of disease pathophysiology and are instrumental in patient stratification, predicting therapeutic responses, and monitoring clinical progression with enhanced accuracy. As companion diagnostics, biomarkers are essential for identifying patients most likely to benefit from targeted or immunomodulatory therapies.

At CliniSciences, we support your programs by providing access to cutting-edge analytical technologies and proven expertise in biomarker assay development and validation. Our CRO team applies a rigorous and tailored approach to identify, qualify, and validate exploratory or predictive biomarkers, in full compliance with regulatory requirements.

Biomarkers are involved at every stage of the drug development cycle, including:

  • Mechanism of action elucidation
  • Pharmacokinetic/pharmacodynamic (PK/PD) modeling
  • Therapeutic response evaluation
  • Monitoring safety and tolerability

Because methodological robustness is critical, we implement highly sensitive, specific, and reproducible assays, tailored to your biological matrices and scientific goals. The choice of technology (e.g., ELISA, multiplexing, immunohistochemistry, RT-qPCR, NGS) is discussed upfront to ensure reliability, clinical relevance, and regulatory success.

With our network of scientific experts and deep-rooted scientific culture, CliniSciences positions itself as a strategic partner to help transform your biomarker research into actionable tools for therapeutic decision-making.

We can provide:
 
Development & validation of assays customized to your specific needs
Adaptation of commercially available kits to your requirements & validation
Transfer of your methods and validation for subsequent use in clinical studies
Transfer of your methods and validation for subsequent use in clinical studies development
Validated and custom panels
  • A wide range of markers: we apply a range of validated markers, either as single markers or within multiplexed approaches.
  • Customization: to align with the sponsor’s project and hypothesis, we develop custom markers and panels.
•••
A variety of eligible samples
  • Diverse origins: we work with samples originating from both clinical and preclinical studies (see our in vivo platform).
  • Sample types: tissue samples (FFPE, Frozen, Fresh) and biological fluids (PBMCs, plasma, Serum,…).
  • Source flexibility: samples can be provided by the sponsor or acquired/generated by CliniSciences.
•••

Technologies for Biomarker Testing

To provide flexible solutions for biomarker testing, CliniSciences offers a broad variety of methods and technologies:

  • RT-MLPSEQ
  • NGS
•••