Precision Medicine Assay Development
Immediate & actionable guidance on developing & validating clinical tests spanning diverse applications based on direct experience developing assays for clinical biomarker testing, clinical laboratories (LDTs) & IVD manufacturers (kits & single-site IVDs).
Clinical Biomarker & Companion Diagnostic Development
Pragmatic clinical biomarker & CDx co-development guidance based on direct Biopharma CDx experience, IVD industry CDx know-how, deep technical CDx assay development acumen & contemporary CDx regulatory insights across diverse biomarkers, specimen types, technologies & indications.
Global Precision Medicine Regulatory Strategy
Deep regulatory insights & intelligence from global Rx & Dx development experience, regulatory submissions for global clinical trials & global IVD regulatory marketing submissions.