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

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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By Anatomise Biostats

The Call for Responsible Regulations in Medical Device Innovation

Clinical Trials, Med-Tech & Medical Device
In the seemingly fast-paced world of medical technology, the quest for innovation is ever-present. However, it is crucial to recognise that the engineering of medical devices should not mirror the recklessness and hubris of exploratory engineering exemplified by the recent Ocean Gate tragedy where the stubborn blinkeredness of figures like Stockton Rush is not kept in check by sufficiently stringent…
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By Anatomise Biostats

Stata: Statistical Software for Regulatory Compliance in Clinical Trials

Biostatistics, Clinical Trials, Med-Tech & Medical Device, Pharma & Drug Development
Stata is widely used in various research domains such as economics, biosciences, health and social sciences, including clinical trials. It has been utilised for decades in studies published in reputable scientific journals. While SAS has a longer history of being explicitly referenced by regulatory agencies such as the FDA, Stata can still meet regulatory compliance requirements in clinical trials. StataCorp…
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By Anatomise Biostats

The Devil’s Advocate: Stata for Clinical Study Design, Data Processing, & Statistical Analysis of Clinical Trials.

Biostatistics, Clinical Trials, Med-Tech & Medical Device, Pharma & Drug Development
Stata is a powerful statistical analysis software that offers some advantages for clinical trial and medtech use cases compared to the more widely used SAS software. Stata provides an intuitive and user-friendly interface that facilitates efficient data management, data processing and statistical analysis. Its agile and concise syntax allows for reproducible and transparent analyses, enhancing the overall research process with…
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