Focused on diagnostics for your success

IVD experience makes all the difference

Beaufort is a global contract research organization (CRO) built around one purpose — ensuring your in vitro diagnostic (IVD) or companion diagnostic (CDx) product successfully reaches the market. Our team is composed of diagnostics-focused experts who have guided hundreds of sponsors through every step of the regulatory, clinical, and quality process.

We have nearly two decades of demonstrated strategic and operational success navigating the unique protocols, best practices, and compliance requirements of IVD clinical studies. We know what questions to ask, as well as the systems and controls necessary to overcome risks, to help you follow the clearest and most efficient path to regulatory clearance or authorization.

Global Integrated Services

  • Clinical Trials

    Clinical Trials

    Clinical Trials

    Efficient trial management, site selection, monitoring, data management and biostatistics.

    Clinical Trial Services
  • Regulatory Affairs

    Regulatory Affairs

    Regulatory Affairs

    Results-focused regulatory strategies, protocol development, and pre- and post-market submission and support.

    Regulatory Affairs
  • Quality Assurance

    Quality Assurance

    Quality Assurance

    QMS design and implementation, gap assessment and remediation, auditing and inspection readiness.

    Quality Assurance

In-depth Knowledge and Areas of Expertise

  • Hospitals / ED / ICU
  • Point-of-care (POC)/Near patient testing
  • PICU/ NICU
  • Physician office laboratory (POL)
  • Professional use
  • Direct-to-consumer (DTC)
  • Over-the-counter (OTC)
  • Rx home use
  • CLIA waiver

  • 510(k)
  • De novo
  • Premarket approval (PMA) and supplements
  • Pre-EUA/EUA
  • CLIA waiver
  • Pre-sub/Q meetings
  • Investigational device exemption (IDE)
  • Technical files/Dossiers
  • International classification and conformity assessments
  • In vitro diagnostic regulations (IVDR)
  • Companion and complementary diagnostics
  • Laboratory developed tests (LTDs)

  • Lateral flow
  • MicroRNA
  • Molecular Dx
  • Next-generation sequencing
  • Mass spectrometry
  • Immunoassay
  • Immunohistochemistry (IHC)
  • Fluorescence in situ hybridization (FISH)
  • Flow cytometry
  • Software
  • Artificial intelligence/Machine learning

  • Infectious disease
  • Oncology
  • Cardiovascular
  • Gastroenterology
  • Nephrology
  • Endocrinology
  • Neurology
  • Hematology
  • Respiratory
  • Women’s Health