Beaufort
MedTech-focused contract research organization providing clinical trial management, regulatory consulting, data management and biostatistics, quality systems, and safety monitoring for medical device and IVD sponsors. Services include end-to-end trial execution (including decentralized and hybrid models), EDC development and data migration, regulatory strategy and submissions (U.S. and global), inspection readiness, and clinical monitoring oversight to support data integrity and regulatory submissions.
Industries
Nr. of Employees
small (1-50)
Beaufort
Norfolk, Virginia, United States, North America
Products
CDx Clinical Trial Services
Specialized clinical trials designed specifically for diagnostic innovations with regulatory success in mind, covering specimen collection protocols, method comparison protocols, and adaptive statistical approaches.
Companion Diagnostics Regulatory and Quality Assurance Services
Beaufort offers regulatory and quality assurance solutions for companion diagnostic (CDx) development and registrations internationally, including regulatory strategy, clinical trial assay development, and quality management system reviews.
Full Service Clinical Monitoring Oversight
Comprehensive on-site monitoring and reporting, with objective and actionable data and early CAPA recommendations to ensure that your trial is on track and prepared for regulatory submission and inspection.
FDA Oversight of LDTs
Knowledge and experience application to align product development with FDA’s proposed rule for greater oversight of laboratory developed tests (LDTs).
IVDR Implementation
Strategic and technical guidance assisting with the implementation of any stage of the IVDR certification process.
TORAMYXIN PMX-20R
An extracorporeal PMX cartridge that selectively removes endotoxin through direct hemoperfusion of circulating blood, used in the treatment of endotoxemic septic shock.
CDx Clinical Trial Services
Specialized clinical trials designed specifically for diagnostic innovations with regulatory success in mind, covering specimen collection protocols, method comparison protocols, and adaptive statistical approaches.
Companion Diagnostics Regulatory and Quality Assurance Services
Beaufort offers regulatory and quality assurance solutions for companion diagnostic (CDx) development and registrations internationally, including regulatory strategy, clinical trial assay development, and quality management system reviews.
Full Service Clinical Monitoring Oversight
Comprehensive on-site monitoring and reporting, with objective and actionable data and early CAPA recommendations to ensure that your trial is on track and prepared for regulatory submission and inspection.
FDA Oversight of LDTs
Knowledge and experience application to align product development with FDA’s proposed rule for greater oversight of laboratory developed tests (LDTs).
IVDR Implementation
Strategic and technical guidance assisting with the implementation of any stage of the IVDR certification process.
TORAMYXIN PMX-20R
An extracorporeal PMX cartridge that selectively removes endotoxin through direct hemoperfusion of circulating blood, used in the treatment of endotoxemic septic shock.
Services
Project management, site selection and activation, monitoring, and close-out support for MedTech and IVD studies.
Regulatory strategy, submission preparation, agency interactions, and post-market lifecycle management for FDA and global markets.
Custom EDC development, data migration, data management, statistical analysis and reporting.
Independent oversight visits, on-site performance evaluations, and inspection readiness support to ensure data integrity and regulatory acceptability.
IVDR implementation, performance study design and submissions, CDx development support, and technical documentation preparation.
Project management, site selection and activation, monitoring, and close-out support for MedTech and IVD studies.
Regulatory strategy, submission preparation, agency interactions, and post-market lifecycle management for FDA and global markets.
Custom EDC development, data migration, data management, statistical analysis and reporting.
Independent oversight visits, on-site performance evaluations, and inspection readiness support to ensure data integrity and regulatory acceptability.
IVDR implementation, performance study design and submissions, CDx development support, and technical documentation preparation.
Expertise Areas
- Clinical trial management
- Clinical monitoring oversight
- Biostatistics and statistical programming
- EDC development and clinical data management
Key Technologies
- Electronic Data Capture (EDC) systems
- eConsent and eSource
- Direct data capture and remote monitoring platforms
- AI/ML models for recruitment and analytics
News & Updates
An eBook developed to help sponsors navigate MedTech clinical trials and readiness.
Describes facility gap assessments and alignment with cGMP for manufacturers seeking U.S. market entry.
Summary of FDA's proposed rule to bring certain laboratory developed tests under IVD regulatory requirements and its implications.
Overview of the ICH E6(R3) final guideline and its implications for interventional clinical trials.
Key takeaways from the 2025 IVD regulatory meeting covering IVDR, AI Act, EUDAMED rollout, and global regulatory trends.
Company milestone reporting 20+ years of experience and operations with team members in over 60 countries.
An eBook developed to help sponsors navigate MedTech clinical trials and readiness.
Describes facility gap assessments and alignment with cGMP for manufacturers seeking U.S. market entry.
Summary of FDA's proposed rule to bring certain laboratory developed tests under IVD regulatory requirements and its implications.
Overview of the ICH E6(R3) final guideline and its implications for interventional clinical trials.
Key takeaways from the 2025 IVD regulatory meeting covering IVDR, AI Act, EUDAMED rollout, and global regulatory trends.
Company milestone reporting 20+ years of experience and operations with team members in over 60 countries.