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…
Read More
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…
Read More
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…
Read More
By Anatomise Biostats

Fake vs Synthetic Data: What’s the difference?

Uncategorized
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…
Read More
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…
Read More
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…
Read More
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…
Read More
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…
Read More
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…
Read More
By Anatomise Biostats

Dynamic Systems Modelling and Complex Adaptive Systems (CAS) Techniques in Biomedicine and Public Health

Uncategorized
Dynamical systems modelling is a mathematical approach to studying the behaviour of systems that change over time. These systems can be physical, biological, economic, or social in nature, and they are typically characterized by a set of variables that evolve according to certain rules or equations. CAS (Complex Adaptive Systems) models are a specific type of dynamical systems model that…
Read More