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
Efficient trial management, site selection, monitoring, data management and biostatistics.Clinical Trial Services
Results-focused regulatory strategies, protocol development, and pre- and post-market submission and support.Regulatory Affairs
QMS design and implementation, gap assessment and remediation, auditing and inspection readiness.Quality Assurance
In-depth Knowledge and Areas of Expertise
- Professional use
- Physician office laboratory (POL)
- Point-of-care (POC)/Near patient testing
- Direct-to-consumer (DTC)
- Over-the-counter/Rx home use
- CLIA waiver
- De novo
- Premarket approval (PMA) and supplements
- 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
- Molecular Dx
- Next-generation sequencing
- Mass spectrometry
- Immunohistochemistry (IHC)
- Fluorescence in situ hybridization (FISH)
- Flow cytometry
- Artificial intelligence/Machine learning
- Infectious disease
- 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