Clinical trials built to move your IVD product forward
In vitro diagnostics clinical studies are inherently unique when compared to other trials. These distinctions impact all aspects of planning, budgeting, management, and execution. This is where you find the true value of a CRO that specializes in diagnostics. Beaufort’s comprehensive clinical trial management services are targeted to address these specialized nuances, guide decision-making, and successfully accelerate your product development.
Our team’s fluency in IVD clinical studies and broad therapeutic experience provides the focus and the proficiency your project demands. Beaufort’s proprietary Diagnostic Clinical Trial Checklist and ISO 9001:2015 certification also helps ensure all activities follow trial protocols, Standard Operating Procedures, and global regulatory guidelines and requirements.
Support from start to finish
Our clinical teams bring decades of experience in IVD study management and work closely across all functional areas to seamlessly integrate project requirements.
- Clinical strategy
- Clinical study design
- Protocol development
- ICF development
- Site/Lab ID and qualification
- Contract negotiation
- IRB/EC submission support
- Site/Lab initiation and training
- Trial Master File setup
- Subject enrollment
- Data collection
- On-site and remote monitoring
- Trial Master File management
- Site close out visits
- Audit preparation
- Clinical study / Performance Evaluation Report development
The right sites for the best results
We work with more than 4,000 clinical sites globally to provide access to the subject populations you need for your IVD study. Whether the right site involves emergency departments, hospital, reference and CLIA labs, or physician offices, we can help target and select the best possible sites for your needs. Our team conducts detailed site feasibility, qualification, and training to maximize enrollment and set your study up for success.