Medical Device Clinical Trial Biostatistical Consulting and Statistical Programming
Why Companies Choose NAMSA
Clinical Trial Projects Annually
Medical Device Clinical Trials Supported
Biostatisticians and Statistical Programmers on Staff
Average Years of Experience in Biostatistics and Clinical Research
An Experienced Team of Clinical Trial Biostatisticians and Statistical Programmers
With an average of 15 years of experience, each clinical research consulting team member is 100% medical device and IVD-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 across all phases of a clinical trial. 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 provides rapid and accurate SAP and TLF turnaround, reducing delays and accelerating the delivery of high‑quality outputs. From Statistical Analysis Plan (SAP) development to the creation of Tables, Listings and Figures (TLFs), our team is structured to deliver fast, reliable, and regulator‑ready statistical results—helping sponsors move confidently from data to decision.
NAMSA Biostatistical and Statistical Programming Services
NAMSA Biostatistics support clients in all capacities and at all stages, from pre-clinical to pivotal clinical trials, and study design consulting to post-completion manuscript support.
Some of NAMSA’s biostatistics and statistical programming solutions include:
- Clinical study design: Adaptive 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 protocol and statistical analysis plan development
- Randomization scheduling
- Statistical analysis: Programming and validation for dataset creation, tables, figures & listings
- Clinical study report
- 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.
CLIENT FEEDBACK
I wanted to thank you for the excellent collaboration identifying the data gap. I told our group that this is exactly the kind of interaction I was hoping for when we selected NAMSA. I also told them that there was a zero chance we would have gotten the same timely feedback from the CRO we worked with on the last project.
David Miller, DPM BiostatisticsProfessional, responsive, supportive. So helpful, and we have learnt so much whilst working alongside the Biostatistics Team.
UK-Based Manufacturer of Wound Care DevicesTake the Next Step
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Frequently Asked Questions (FAQs)
What should be included in a Statistical Analysis Plan (SAP) for a medical device study?
A medical device SAP should outline the study objectives, endpoints, analysis populations, statistical methods, handling of missing data, device specific performance metrics, hypothesis testing plans, interim analyses (if any), subgroup analyses. Shells for all tables, listings, and figures are also helpful and should be developed in conjunction with the SAP.
How do you determine the appropriate sample size for a medical device clinical study?
Sample size calculations for device trials depend on the endpoint type (e.g., performance goals, diagnostic accuracy, noninferiority margins, reliability), expected variability, desired confidence intervals, regulatory thresholds, and feasibility constraints. Inputs typically include historical performance data, clinical relevance, and FDA/EU MDR expectations for statistical rigor.
What statistical considerations are required when establishing device performance goals?
Performance goals should be based on predicate device performance, clinical literature, real world evidence, or consensus standards. Biostatistics supports the justification through meta analysis, pooled analyses, or literature based estimations, ensuring the goal is clinically meaningful and aligns with regulatory requirements for the device type.
What analyses are typically included in a medical device Clinical Study Report (CSR)?
A CSR commonly includes accountability of subjects, baseline characteristics, device exposure/use summaries, primary and secondary endpoint analyses, missing data assessments, safety analyses, subgroup results, poolability analyses, protocol deviation summaries, sensitivity analyses, and descriptions of statistical methods. Diagnostic devices also include ROC curves, Bland-Altman plots, and agreement statistics.
What is included in a statistical review of a medical device protocol?
A biostatistical protocol review covers endpoint selection, estimand clarity, statistical design choice (superiority, noninferiority, performance goal), randomization strategy, missing data mitigation, interim analysis rules, justification for sample size, and appropriateness of statistical assumptions for the target device and indication. Having a Biostatistician’s input in the early stages of study design can mitigate potential issues later in the study.
How do you handle missing data and protocol deviations in device trials?
Approaches depend on device type and endpoint. Strategies may include multiple imputation, sensitivity analyses, tipping point analyses, and/or predefined rules for handling unusable data. Having a well-defined SAP which outlines exact processes is necessary to ensure transparency and regulatory acceptability.
Do you support adaptive or Bayesian designs for medical devices?
Yes. Adaptive designs may include sample size re estimation or early stopping rules for futility or success. Bayesian methods are increasingly used in device studies for borrowing information from historical or real world datasets. We support model specification, prior selection, operating characteristic simulations, and regulatory justification.
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