By Anatomise Biostats

Strategic Sample Size Solutions for MedTech Startups: Navigating Software vs. Expert Support

Uncategorized
A comprehensive guide for medtech sponsors and clinical teams on optimising sample size calculations for clinical trial success The Critical Crossroads Every MedTech Sponsor Faces As a sponsor or member of a clinical team in the MedTech industry, you're tasked with making critical decisions that impact the success of clinical trials. One of the most pivotal choices you'll face is…
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By Sarah Baker

Treatment-Adaptive vs Response-Adaptive Randomisation: A Practical Guide for Medtech Trials

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Medical device trials increasingly incorporate adaptive randomisation to improve efficiency and patient outcomes. Two main approaches have emerged: treatment-adaptive randomisation (TAR), which modifies allocation probabilities at pre-planned interim analyses, and response-adaptive randomisation (RAR), which updates allocations continuously based on patient outcomes. The choice between these methods depends on trial characteristics including endpoint timing, data infrastructure, regulatory requirements, and scientific objectives.…
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By Sarah Baker

Causal Inference for Precision Medicine in Medtech R&D and Clinical Studies

Biostatistics, Clinical Trials, Med-Tech & Medical Device
Precision medicine is reshaping the landscape of medtech by tailoring treatments and diagnostics to each patient’s unique genetic, molecular, and clinical profile. As innovative devices and diagnostics enter the market, it becomes critical to understand not only whether they work, but why they work. Causal inference offers a robust statistical framework for distinguishing true treatment effects from mere associations, a…
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By Sarah Baker

Analytics for Precision Medicine in Medtech R&D and Clinical Trials

Biostatistics, Clinical Trials, Med-Tech & Medical Device
Precision medicine is transforming healthcare by allowing treatments and diagnostics to be tailored to the unique genetic, molecular, and clinical profiles of individual patients. As research and clinical evaluation evolves, sophisticated analytics have become essential for integrating complex datasets, optimising study designs, and supporting informed decision-making. This article will explore 3 core quantitative approaches core to supporting the development of…
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By Anatomise Biostats
Biostatistics, Clinical Trials, Med-Tech & Medical Device, Pharma & Drug Development, Uncategorized
CRF Design for Clinical Studies: The Distinct Roles of Data Managers vs Biostatisticians In medtech clinical trials, the Case Report Form (CRF) is more than a tool for collecting data—it’s the backbone of the study. From capturing critical safety outcomes to evaluating device performance, a well-designed CRF ensures that the study’s goals are met efficiently and reliably. Achieving this balance…
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By Sarah Baker

Expert Opinion: Why Biostatistics Qualifications Matter in Med-Tech Industry Clinical Trials.

Biostatistics, Clinical Trials, Med-Tech & Medical Device, Pharma & Drug Development, Uncategorized
Consider the consequences if a medical doctor, without a formal medical education or licensing, were to diagnose and treat patients. Such a doctor might misunderstand symptoms, choose the wrong treatments, or even harm patients due to lack of understanding and experience. Similarly, an unqualified biostatistician might incorrectly analyse data, misinterpret statistical significance, or fail to recognise biases and patterns essential…
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By Anatomise Biostats

Biometrics & Clinical Trials Success:

Biostatistics, Clinical Trials, Med-Tech & Medical Device, Pharma & Drug Development, Uncategorized
Why Outsourcing a Biostatistics Team is Pivotal to the Success of your Clinical Trial Clinical trials are among the most critical phases in bringing a medical device or pharmaceutical product to market, and ensuring the accuracy and integrity of the data generated is essential for success. While some companies may feel confident relying on their internal teams, especially if they…
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By Anatomise Biostats

Fake vs Synthetic Data: What’s the difference?

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The ethical and accurate handling of data is paramount in the domain of clinical research. As the demand for data-driven clinical insights continues to grow, researchers face challenges in balancing the need for accuracy with the availability of data and the imperative to protect sensitive information. In situations where quality real patient data is not available, synthetic data can be…
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By Anatomise Biostats

The Role of Clinical-Translational Studies in Validation of Diagnostic Devices

Biostatistics, Med-Tech & Medical Device
Clinical-translational studies refer to research studies that bridge the gap between early-stage diagnostic development and real-world clinical application. In a diagnostics context these studies focus on translating promising diagnostic technologies from laboratory research (preclinical stage) to clinical practice, where they can be validated, assessed for clinical utility, and eventually integrated into routine healthcare settings. The primary goal of clinical-translational studies…
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By Anatomise Biostats

Checklist for proactive regulatory compliance in medical device R&D projects

Clinical Trials, Med-Tech & Medical Device
In today’s competitive and highly regulated medical device industry, ensuring regulatory compliance is not merely a legal obligation—it is fundamental to guaranteeing the safety, efficacy, and overall quality of your innovations. Whether you are developing a new device or conducting clinical trials, a proactive and integrated approach to compliance can help you navigate the complexities of the regulatory landscape. This…
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