Broad Translational and Biomarker experience, Pre-IND through Ph3 and CDx Development
Including Regulatory experience IND through sNDA including Biomarker discussions with HA
Robust biomarker planning for Ph 1-3 tailored to your asset, indication, trial and budget
Strategic planning, regulatory considerations, study oversight and troubleshooting
Develop a novel clinical assay or transfer an existing research assay to a CLIA certified central lab
Laboratory selection, assay design, validation, troubleshooting, data analysis and interpretation
Robust Biomarker Strategy
Fit for Purpose biomarkers tailored to your asset, indication, trial and budget
Strategic planning, regulatory considerations, trial oversight and troubleshooting
Clinical Grade Assays
Develop a novel clinical assay or transfer an existing assay to a CLIA certified central laboratory
Lab Selection, Assay Design, Validation, Oversight & Troubleshooting
Broad Experience
Translational and Biomarker support from preclinical through Ph3 including CDx development
Significant Regulatory experience from IND through sNDA including leading Biomarker discussion with Health Authorities
