Clinical Monitoring & Site Management

Protecting the Quality & Integrity of Your MedTech Trial

Beaufort delivers rigorous clinical monitoring and site management to ensure data quality and regulatory compliance across all your study sites.

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Elevating Standards, Eliminating Risk

Our specialized clinical monitors bring deep experience across all classes of medical devices, diagnostic technologies, and digital health platforms. Most importantly, we maintain the same monitoring team throughout your study, providing consistency that builds site relationships and ensures seamless oversight.

Launching Clinical Site Excellence

Our activation process transforms clinical sites into high-performing research centers through comprehensive preparation, tailored training, and meticulous setup of all study-specific systems and processes.

  • Assure patient safety and protection by ensuring site adherence to privacy regulations, IRB requirements and local and federal regulations
  • Conduct comprehensive site initiation visits with technology-specific training
  • Implement robust traceability system for trial materials to demonstrate accountability and integrity
  • Establish site-specific monitoring
  • Configure data collection systems with site workflow integration
  • Deliver hands-on training for technical procedures and assessments as indicated in the protocol
  • Verify and maintain regulatory documentation

Ensuring Rigorous Compliance

Our specialized clinical monitors maintain continuous oversight of all study activities, combining strategic on-site visits with advanced remote monitoring technologies to ensure complete protocol adherence and data integrity.

  • Perform risk-based on-site and remote monitoring visits
  • Conduct thorough source data verification with critical data focus
  • Track protocol compliance and procedural adherence
  • Verify proper adverse event reporting and documentation
  • Review data consistency, completeness, and accuracy
  • Assess site performance metrics against established standards

Elevating Site Performance

We proactively identify and address potential challenges before they impact your study, implementing targeted interventions that optimize site operations and improve overall efficiency.

  • Analyze site metrics to identify issues and/or improvement opportunities
  • Develop and implement site-specific action plans
  • Provide additional training for underperforming areas
  • Optimize patient recruitment and retention strategies
  • Streamline data collection processes to reduce site burden
  • Share best practices across sites to elevate performance

Ensuring Successful Completion

Our methodical clinical study closeout process ensures all site activities are properly finalized, with complete documentation, resolved queries, and full regulatory compliance for seamless study completion.

  • Conduct comprehensive site closeout visits
  • Verify resolution of all outstanding queries
  • Ensure completion of all essential documentation
  • Confirm proper specimen traceability, device accountability and dispositions
  • Finalize regulatory submissions and site files
  • Prepare sites for potential regulatory inspections

Beaufort’s clinical trial monitors represent the Gold Standard!

– Senior Associate Director

Top 15 Global Life Sciences Company

Safeguarding Success for Your Trial

We protect clinical trial integrity through expert oversight, strong site relationships, and risk-based monitoring—ensuring quality data, regulatory compliance, and consistent execution at every step.

MedTech Specialization

Our clinical monitors receive comprehensive training specific to medical technology categories, ensuring true expertise in your study’s unique requirements, from device accountability to diagnostic result verification.

Strategic Risk-Based Monitoring

Our tailored approach focuses resources where they provide maximum value, enhancing quality while optimizing efficiency through technology risk profile assessment and targeted verification.

Site Relationship Excellence

We believe successful trial outcomes begin with productive site relationships built on mutual respect, clear communication, and consistent monitoring personnel assignment.

Quality-Focused Oversight

Our clinical monitoring emphasizes quality by design, identifying and addressing issues before they impact study integrity through comprehensive oversight and early intervention.