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Precision Medicine Solutions

Medical Devices & Diagnostics

Product Development

  • User and market requirements
  • Assay development and validation (software, IHC, NGS, DNA/ctDNA, expression profiling, etc.)
  • Risk and clinical assessments
  • Gap analysis
  • Regulatory support

Clinical Trials

  • Diagnostic protocols/reports
  • Operational support
  • Companion diagnostics strategy
  • Regulatory support

Drug Development

Biomarker Development

  • Platform evaluations & recommendations
  • Early Development
  • Biomarker validation and clinical strategy

Companion Diagnostics

  • Technology & partner evaluations
  • Program strategy
  • AV & CV strategies and/or technical guidance
  • Regulatory support

Precision Medicine Marketing

Companion Diagnostics & Medical Devices

  • Market analysis
  • Review/creation of pitch decks
  • Ad hoc consultations
  • Companion diagnostic education materials

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