Preclinical and Clinical Biomarkers

Biomarker qualification is widely conducted in preclinical and clinical development for understanding mechanism of action, dose selection, patient stratification and enrichment, and assessments of safety and efficacy.

Through analytical services in biostatistics, bioinformatics, and data science, BSSI helps clients to gain insight into preclinical and clinical biomarkers and their development of precision medicine.

Examples of Experience in Preclinical Studies

  • Analysis and visualization of gene expression data from tissues of model organisms and linking to human genes;
  • Machine learning applications in patient derived tumor xenografts (PDX) modeling;
  • Genomic studies of complex traits in animals such as dogs, pigs and cows.

Expertise in Clinical Biomarker Research

  • Biomarker-driven clinical trial design and experimental design within trials;
  • Consulting support for selecting biotechnologies and vendors in biomarker experiments;
  • Processing and quality control of raw biomarker data from various technologies and platforms;
  • Analysis of relationship between biomarkers and clinical endpoints in search of predictive, prognostic, disease, or monitoring biomarkers;
  • Patient stratification in differentiating disease, efficacy, or safety profiles;
  • Interpretation of biomarker results in the context of biology and statistics.