Infectious Disease CRO Solutions

Guiding Infectious Disease Technologies from Concept to Clearance

Beaufort provides specialized expertise in infectious disease medical technology trials, delivering efficient validation studies for diagnostic, monitoring, and therapeutic devices across diverse pathogens with demonstrated regulatory success.

Talk to Our Infectious Disease Team
A medical professional in protective gear takes a blood sample from a patient wearing a medical mask.

Your Partner in Advancing Infectious Disease Technologies

Our infectious disease team combines extensive microbiology expertise with operational excellence to navigate the unique complexities of pathogen detection and treatment studies. From rapid diagnostic validation to therapeutic device assessment, we deliver customized solutions that accelerate development timelines while maintaining scientific integrity and regulatory compliance.

Strategic Design for Infectious Disease Technology Validation

Our infectious disease specialists design studies that address the unique challenges of pathogen detection and treatment technologies. We implement innovative approaches to sample collection, reference method comparison, and clinical utility assessment while balancing analytical and clinical validation requirements.

  • Reference method comparison study designs
  • Point-of-care diagnostic validation testing
  • Specimen collection and handling protocols
  • Seasonal pathogen study implementation
  • Site selection for specific pathogen prevalence
  • Multi-pathogen panel validation strategies

Navigating Infectious Disease Diagnostic Regulations

Our regulatory experts provide strategic guidance through evolving infectious disease frameworks, from pre-submission planning through approval and beyond. We navigate evolving requirements for emergency use authorization, pandemic preparedness, and antimicrobial resistance technologies with a focus on regulatory efficiency.

  • FDA infectious disease pre-submission strategy
  • IVDR classification for pathogen detection technologies
  • Emergency Use Authorization application development
  • Global infectious disease regulatory approaches
  • Antimicrobial resistance technology pathways
  • Post-market surveillance planning for evolving pathogens

Advanced Analytics for Infectious Disease Technology Validation

Our infectious disease data teams specialize in the unique statistical challenges of pathogen detection research. We implement sophisticated approaches to sensitivity/specificity analysis, limit of detection determination, and clinical correlation to maximize the value of your clinical data.

  • Diagnostic accuracy statistical analysis
  • Limit of detection/quantitation assessment
  • Cross-reactivity and interference evaluation
  • Prevalence-adjusted performance calculations
  • Multi-site reproducibility analysis
  • Analytical and clinical validity correlation

Quality Excellence for Infectious Disease Research

Our quality systems ensure the integrity of your infectious disease data while maintaining operational efficiency. We implement tailored approaches to risk-based quality management with targeted oversight of critical laboratory equipment and processes.

  • Microbiological reference laboratory qualification
  • Specimen integrity assurance
  • Testing procedure validation
  • Site microbiology procedure standardization
  • Biosafety protocol compliance monitoring
  • Regulatory inspection readiness

We would not have even been able to produce the BinaxNOW COVID-19 test if not for the hard work from each of you. When we were in the thick of it, you came through with data monitoring and data lock, hitting those outrageous timelines. Thank YOU for making it possible.

– Clinical Trial Manager, Clinical Affairs

Abbott Rapid Diagnostics

Why Choose Beaufort for Infectious Disease Clinical Trials?

Beaufort combines scientific expertise with innovation to deliver compliant infectious disease trials designed to accelerate breakthroughs in care.

  • Pathogen Expertise

    Our teams bring a deep understanding of microbiology and infectious disease diagnostics.

  • Regulatory Insight

    We navigate evolving infectious disease regulatory requirements with strategic foresight.

  • Operational Experience

    Our tailored processes address the unique challenges of pathogen detection studies.

  • Data Excellence

    We implement specialized approaches to diagnostic accuracy analysis and validation.

  • Global Capabilities

    We maintain site networks with expertise in region-specific and seasonal pathogens.

Diverse Patient Populations in Infectious Disease Research

Beaufort’s infectious disease trials encompass diverse patient populations across outpatient, emergency, and intensive care settings. We excel at implementing studies during seasonal outbreaks, in resource-limited environments, and for specialized populations, including immunocompromised patients, pediatrics, and at-risk communities. Our site selection strategies have proven particularly effective for studies requiring specific pathogen prevalence and geographic diversity.

Infectious Disease CRO Solutions

Infectious Disease Frequently Asked Questions

Get answers to common questions about infectious disease-focused trials and clinical research services.

As an infectious disease CRO, we implement flexible enrollment strategies incorporating multiple geographic regions, year-round capabilities, and pre-identified surge capacity at experienced sites. Our approach includes real-time epidemiological monitoring, standby site activation protocols, and accelerated startup processes to rapidly respond to outbreak opportunities.

We develop comprehensive reference testing protocols using composite gold standards when appropriate, incorporating multiple methodologies and adjudication processes. Our teams coordinate centralized reference testing with rigorous quality control, blinding procedures, and specialized sample handling to ensure valid comparisons.

Our teams develop custom validation strategies incorporating phylogenetic analysis, synthetic controls, and reference laboratory partnerships specialized in novel pathogen characterization. We implement innovative approaches to analytical validation while engaging early with regulatory authorities on appropriate clinical validation frameworks.

We have extensive experience implementing usability and performance validation across emergency departments, physician offices, and resource-limited settings. Our approach addresses real-world variables, including operator training levels, environmental factors, and workflow constraints, to ensure technologies perform effectively in intended use settings.

We design globally harmonized protocols with region-specific adaptations for local pathogen prevalence, standard of care, and regulatory requirements. Our global site network includes specialized infectious disease centers with historical pathogen prevalence, along with customized monitoring approaches for international sites to ensure consistent data quality across regions.