Fast-Track Your Path to First Patient In
Effective study start-up is the foundation of clinical trial success. Our deep background ensures your trial benefits from optimized timelines without compromising quality, all delivered through cross-functional teams that never lose sight of your end goal.
Setting the Foundation
Our comprehensive planning process establishes the critical groundwork for efficient study execution while maintaining the flexibility to pivot as needs evolve.
- Protocol development and optimization for target endpoints
- Risk assessment and mitigation planning
- Regulatory pathway determination
- Feasibility assessment
- Budget and timeline development
- Study management plan creation
Maximizing Site Success
We identify and activate sites with proven device and diagnostic study experience, using our proprietary database to match your specific technology with investigators who deliver quality performance.
- Data-driven site identification and selection
- Site capability and patient population assessment
- Pre-qualification and qualification visits
- Investigator and site staff training
- Essential document collection and management
- Site relationship management
Driving Regulatory Success
Our experts navigate the trial start-up landscape specific to medical devices and diagnostics, ensuring compliance while optimizing timelines through strategic approaches.
- Ethics committee/IRB submission
- Regulatory authority interactions
- Clinicaltrial.gov registration
- Implement quality and GCP standards
- Train and qualify investigators
- Prepare for global compliance
Seamless Implementation
We ensure all operational components are in place for a smooth study launch through our process that identifies opportunities to conduct activities simultaneously where possible.
- Site contract and budget negotiation
- Investigational product management and distribution
- Data management system setup
- Central lab and vendor coordination
We have worked with a number of large CROs, and due to your flexibility, we now prefer to work with Beaufort. We don’t get a lot of upfront notice when starting most projects. That you can step in fast to help cover our various needs is very helpful. We could not have done the current project without you.
Smarter Start-Up. Smoother Study.
We accelerate study start-up through thoughtful planning, proven processes, and strategic execution—laying the groundwork for smoother trials, stronger sites, and faster first-patient-in.
Meticulous Study Start-Up Processes
We’ve engineered our start-up procedures to specifically meet the needs of device and diagnostic studies, applying proven strategies that align with client needs while always maintaining flexibility to strategically pivot to meet milestones.
Pre-Study Planning Excellence
Our proactive approach begins well before traditional start-up, with strategic planning that prevents common delays through comprehensive feasibility analysis and early regulatory alignment.
Strategic Site Selection
Our data-driven approach identifies sites with proven performance in your specific therapeutic area and indication, strategically selecting investigators who consistently deliver quality outcomes and robust enrollment metrics.
Parallel Processing Methodology
Our innovative approach accelerates timelines by identifying opportunities to conduct activities simultaneously, from regulatory submissions to site qualification.
