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Research & Development

  • Biomarker discovery and validation (molecular, protein, other)
  • Platform agnostic, your platform or ours
  • Assay/kit development and validation
  • Platform evaluation and automation
  • Studies to establish a biological baseline
  • Broad, multi-platform technology capability (no bias)
  • LDT/custom development/clinical validation
  • NGS platforms—Illumina, Thermo Fisher, etc.
  • PCR platforms—Qiagen, Thermo Fisher, BioRad, etc.

Clinical Trials & Consulting

  • Complete clinical trial services, program management, and support
  • Clinical trial strategic consulting
  • Reference trial testing services
  • Clinical primary site testing
  • Analytical and clinical testing
  • Complete data management program support

Regulatory & Quality

  • Regulatory strategy (e.g., FDA)
  • Regulatory agency interactions
  • IVD PRE-IDE, PMA, and 510(k) filings
  • International regulatory filings
  • Compliance auditing and consulting
  • Compliant labeling
  • Software documentation
  • Third-party review by Accredited Persons (AP)
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