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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