Demand diagnostic expertise

Accelerating your success with integrated clinical trial services

Beaufort offers a full suite of clinical trial services for in vitro diagnostic (IVD) manufacturers honed by decades of experience specializing in diagnostic studies. This concentration results in accelerated product development and commercialization for our clients. Our dedicated IVD team provides an unmatched combination of data science and trial management expertise to effectively and efficiently bring your product to market.

Three experts in lab coats discuss clinical trial management.

Clinical Trial Management

Beaufort provides comprehensive expertise to solve the specific risks and challenges of your clinical trial with full-service integrated solutions. From study start-up through enrollment to close-out, our experts leverage data-driven processes and provide a top-to-bottom critical review of all decision points that impact the success of your clinical trial.

  • Study design and protocol development
  • Site selection, qualification, and initiation
  • Study monitoring
A set of line and bar graphs overlay a stethoscope resting on a table.

Data Management

We understand the value and significance of applying a data-centric approach to your trial. Our data science experts leverage decades of diagnostic, therapeutic, and regulatory experience to ensure data integrity, quality, and consistency, and that your data is submission-ready.

  • Database design and development
  • Site support and user training
  • Data collection, analysis, and security
A biostatician explains the data on his computer screen to the professional sitting next to him.

Biostatistics

Beaufort applies a deep understanding of statistical methodology to provide tailored solutions that lead to timely, accurate, and actionable insights. Our biostatisticians work to maximize data quality to help you make smart and fast decisions for the success of your study.

  • Statistical consulting
  • Statistical analysis plan (SAP) development
  • Statistical programming and validation

A shared purpose for exceptional clinical trial results

Your success is our success. Beaufort focuses on the unique aspects of your diagnostic product to anticipate challenges early, maximize agility in its clinical trial management, and ensure the highest level of study performance. From concept to commercialization, we are dedicated to the success of your IVD product.

Improved IVD research performance
Improved IVD research performance
Driven by broad experience in the specific requirements and nuances of diagnostic studies.
Reduced time to market
Reduced time to market
Enabled by well-coordinated and outcome-driven decision-making from start to finish.
Highly successful clinical trials
Highly successful clinical trials
Guided by efficient and adaptive clinical trial management.
Maximized project viability
Maximized project viability
Grounded in proven, successful protocol and study designs.
High-Performing Investigators and Sites
High-Performing Investigators and Sites
Ensured by rigorous evaluation processes and our proprietary site database.
Better Data Integrity and Quality
Better Data Integrity and Quality
Accomplished with proven database design, collection and management.

Broad IVD experience

Intended Use Settings

  • Professional use
  • Physician office laboratory (POL)
  • Point-of-care (POC)/Near patient testing
  • Over-the-counter/Rx home use
  • Self-testing/At-home testing
  • CLIA waiver
  • Direct-to-consumer (DTC)

Therapeutic Areas

  • Infectious disease
  • Oncology
  • Cardiovascular
  • Gastroenterology
  • Nephrology
  • Endocrinology
  • Neurology
  • Hematology
  • Respiratory
  • Women’s Health

IVD Technologies

  • Immunoassay
  • MicroRNA
  • Molecular Dx
  • Next-generation sequencing
  • Mass spectrometry
  • Lateral flow
  • ICH
  • FISH
  • Flow cytometry
  • Software
  • AI/Machine learning