Medical Device Clinical Trial Biostatistical Consulting

An Experienced Team of Clinical Trial Biostatisticians and Database Developers

With an average of 20 years of experience, each clinical research consulting team member is 100% medical device-focused and understands the nuances and requirements of medical device statistics and data and how to deliver a custom-designed program that maximizes biostatistics efforts and outcomes.

Our biostatistics team works in parallel with our study management and data management teams to offer each client a custom-designed program that maximizes biostatistics efforts and outcomes. Leveraging our vast knowledge and expertise in medical devices, our biostatisticians capture, analyze and present data from clinical trials to provide the clinical research evidence you need to be successful.

NAMSA Biostatistical Services

Some of NAMSA’s biostatistics and statistical programming solutions include:

• Adaptive study design
• Clinical study design: endpoint selection, sample size calculations and power analysis
• Data analysis for scientific papers or regulatory submissions
• Data Monitoring Committee (DMC) and Data Safety Monitoring Board (DSMB) membership and support
• Global regulatory authority meetings and conferences on statistical design and data analysis
• Medical device data analysis and statistical reports
• Clinical trial protocols and statistical analysis plans preparation
• Randomization scheduling
• Statistical analysis preparation: programming and validation for dataset creation, tables, figures & listings
• Targeted biostatistics consulting

Healthcare Claims Data

Claims data offers a unique lens into real-world clinical practice, capturing usage patterns, outcomes, and costs across diverse patient populations, insights that traditional clinical trials often miss. NAMSA empowers medical device and IVD manufacturers to generate meaningful insights from large-scale healthcare claims data. Whether you’re seeking to support market access, refine your value proposition, or benchmark against competitors, our experts help you turn complex data into strategic clarity. Our biostatistics team can support you:

• Utilization & Adoption Trends: Understand how your device is being used across diverse healthcare settings and patient populations, not just how much is being sold.
• Comparative Effectiveness & Cost Analysis: Benchmark your product against competitors by evaluating procedure types, complication rates, and downstream costs.
• Longitudinal Analysis: Applied time-to-event methodologies to assess retreatment rates and long-term outcomes, offering a robust view of product performance in real-world settings.
• Population-Level Insights: Access and analyze data across millions of patients to identify patterns by age, geography, provider type, and more.

With deep expertise in biostatistics, therapeutic areas, and claims data analytics, NAMSA transforms complex datasets into clear, impactful narratives. Whether you’re preparing for payer discussions, refining your market strategy, or supporting regulatory submissions, we deliver the evidence you need to move forward with confidence. We don’t just analyze data, we help you understand what it means, how to act on it, and how to communicate it to stakeholders.