THE IFFERENCE - BeaufortTHE BEAUFORT CRO DIFFERENCE Focus on Diagnostics Customized Solutions. Depth...
Transcript of THE IFFERENCE - BeaufortTHE BEAUFORT CRO DIFFERENCE Focus on Diagnostics Customized Solutions. Depth...
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THE BEAUFORT CRO DIFFERENCE
Focus on Diagnostics
Customized Solutions
Depth of Experience
History of Proven Results
9001:2015
Commitment to Quality
Founded In
2004
Choose Beaufort Because We Accelerate Medical Innovation
LEARN MORE
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Improved IVD research performance
Well-run clinical trials
Enhanced data integrity
Better control and quality
High-performing investigators, sites and labs
Reduced time to market
OUTCOME-FOCUSED EXPERTISE
Our experience with hundreds of successful 510(k) clearances, PMA approvals, clinical trials,
and consulting engagements ensures that our clients receive:
“Beaufort’s ability to grasp and articulate clinical 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 Diagnostic Company
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BEAUFORT CRO SERVICESBeaufort maximizes operational and regulatory success by providing more
specialized IVD experience than any other CRO
Regulatory Affairs• Regulatory Strategies• Protocol Development• Pre & Postmarket Submissions
Clinical Trial Services• Clinical Trial Management• Monitoring Services• Data Management & Biostatistics
Quality Solutions• On-site Gap Assessment• Remediation Services• Auditing Support
Staffing Solutions• Flexible Staffing Models• Fully Vetted Network• Global Reach
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WE KNOW DIAGNOSTICS
Beaufort’s team is highly proficient in managing all aspects of clinical trials and developing regulatory strategies across a wide range
of technologies and therapeutic areas.
• CDx• POC• OTC/Home
Use• LDTs• CLIA Waiver• Genomic• Clinical
Lab-based
Areas of Expertise
IVD Technologies
Regulatory Pathways
Therapeutic Areas
• Molecular Dx• NGS• Clinical
Chemistry• Immunoassay• IHC• FISH• Flow
Cytometry
• De novo• 510 (k)• PMA• IDE
• Oncology• Infectious
Diseases• Cardiology • Nephrology• Immunology• Women’s
Health
Beaufort’s Experience
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300+ Regulatory Submissions
including 510(k)s, PMAs, IDEs and
CE-Marks
250+ Clinical Trials Across a
Wide Variety of Indications and
Testing Platforms
2,000+ Clinical Professionals in Over 40 countries
14 Years of Beaufort Leadership
in the IVD Industry
BEAUFORT BY THE NUMBERS
600+ Clinical Study Sites Around the Globe
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Client-Driven Approach
Tested and Proven Solutions
Deadline and Communications Focused
Flexible and Nimble to Meet Client’s Needs
Highly-Skilled Global Team
Deep Industry Expertise
BEAUFORT’S COMMITMENTTO BEST-IN-CLASS SOLUTIONS
Our People, Our Processes, Our Solutions
“Beaufort was instrumental in helping us launch a product line that was a key component of our growth and strategic plans.”
Divisional Vice President, Top 10 Global Healthcare Company
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FOR MORE INFORMATION
Email: [email protected]
Phone: 757.383.6000
999 Waterside Drive · Suite 1010 · Norfolk, Virginia 23510
BeaufortCRO.com