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