In-Vitro Diagnostics (IVD) Services

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

Efficient trial management, site selection, monitoring, data management and biostatistics.
Clinical Trial Services
Regulatory Affairs

Regulatory Affairs

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

We would not have even been able to produce the BinaxNOW COVID-19 test if not for the hard work from each of you. When we were in the thick of it, you came through with data monitoring and data lock, hitting those outrageous timelines. Thank YOU for making it possible.

– Clinical Trial Manager, Clinical Affairs, Abbott Rapid Diagnostics

Beaufort’s ability to grasp and articulate the clinical medical value in the field of in vitro diagnostics enabled our company to strategically align our FDA trials and submissions to meet the ever-increasing standards of the FDA.

– Manager, Clinical and Scientific Affairs, Leading Global Diagnostics Company

Beaufort, for me, has been critical in filling gaps in knowledge, and bringing a CDx to market. They have been helpful in providing insights and guidance on the best regulatory approach.

– Director, Biomarkers and CDx Development, Leading Biomedical Company

Focused on diagnostics for your success

IVD experience makes all the difference

Global Integrated Services

Clinical Trials

Clinical Trials

Regulatory Affairs

Regulatory Affairs

Quality Assurance

Quality Assurance

In-depth Knowledge and Areas of Expertise

Intended Use Settings

Regulatory Pathways

IVD Technologies

Therapeutic Areas

We would not have even been able to produce the BinaxNOW COVID-19 test if not for the hard work from each of you. When we were in the thick of it, you came through with data monitoring and data lock, hitting those outrageous timelines. Thank YOU for making it possible.

Beaufort’s ability to grasp and articulate the clinical medical value in the field of in vitro diagnostics enabled our company to strategically align our FDA trials and submissions to meet the ever-increasing standards of the FDA.

Beaufort, for me, has been critical in filling gaps in knowledge, and bringing a CDx to market. They have been helpful in providing insights and guidance on the best regulatory approach.