Experience with a Global Reach
© 2025 BEAUFORT all rights reserved
Beaufort CRO for Driving Success in Your IVD Trial
Navigating the complex world of in vitro diagnostics demands specialized expertise. For 25 years, Beaufort has guided diagnostic companies from regulatory strategy to clinical trial design and management to market clearance and beyond with precision and efficiency.
Unlike traditional CROs, we're purpose-built for IVD trials. Our specialized teams become an extension of yours, adapting to your unique challenges while minimizing risk. With Beaufort, you have a dedicated and specialized partner committed to accelerating your timeline and maximizing your diagnostic development success.
Let’s work together to advance your IVD commercialization journey. Complete the form to connect with one of our experts today.
1,000+
Global IVD Clinical Trials
500+
Global Regulatory Submissions
4,000+
Clinical Study Sites
94%
Clients Rate Us Higher Than Other CROs
Specialized Expertise Across the IVD Spectrum
Our deep knowledge and experience spans the complete spectrum across all therapeutic areas, in both established and emerging diagnostic technologies, and through all regulatory pathways.
Broad but specialized knowledge
in all therapeutic areas for IVDs
- Oncology
- Infectious Disease
- Cardiovascular
- Neurology
- Urology
- Women’s Health
- Gastroenterology
What Our Clients Say
Why Beaufort?
Beaufort is a MedTech-focused CRO with deep expertise in accelerating IVD, medical device, and digital health innovations to market. Unlike traditional CROs, we're purpose-built for MedTech companies, combining specialized industry knowledge with hyper-agile teams that adapt seamlessly to your unique challenges.
Our customer-centric approach transforms us into a true extension of your team—delivering tailored solutions across regulatory strategy, clinical study design, validation, and market clearance. With Beaufort's solution-oriented philosophy, we navigate obstacles efficiently, minimize risks, and accelerate timelines. The end result is your diagnostic and device innovations reach the market with speed, precision, and confidence that other CROs simply cannot match.
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I want to thank you for the incredible work you have done on Abbott’s studies over the past two years. I hope that when you see and hear about the BinaxNOW COVID-19 test you realize the critical role you played in making this test possible. The study was very long and ever-changing, and you endured each and every turn.
Clinical Trial Manager, Clinical Affairs
Abbott Rapid Diagnostics
"
Thank you for all of you support with preparing the updated analyses for the response to FDA for the 510(k). We have had a great experience working with Beaufort, and earlier today, I recommended Beaufort to several of our vendors.
Senior Manager, Promega
"
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.
Director, Clinical and Scientific Affairs
Siemens Laboratory Diagnostics
Full Range of IVD Services
Our IVD-focused experts design studies that address the unique requirements of your diagnostics and pivot seamlessly as needs evolve.
Clinical trial project management
Study start-up
Patient recruitment
Clinical monitoring & site management
Clinical supplies management
Medical affairs & safety management
Data management & biostatistics
Medical writing
Regulatory affairs consulting
Quality assurance
Dedicated support across novel diagnostic innovations and technologies
- Next-generation sequencing
- Digital and multiplex PCR
- Microfluidics
- Liquid biopsies
- AI and machine learning integration
- Digital health and continuous monitoring systems
Expert guidance through your desired regulatory pathway
- Nephrology
- Endocrinology
- Hematology
- Respiratory
- Immunology
- Musculoskeletal
- And others
- 510(k) clearance
- De novo classification
- Premarket approval
- Laboratory developed test
- Pre-submission
- Investigational device exemption
- CLIA waiver
- Emergency use authorization
- International classification and conformity assessment
- Post-market support
