Stata: Statistical Software for Regulatory Compliance in Clinical Trials
Stata has been widely used for decades in various research domains such as economics, biosciences, health and social sciences, including clinical trials. It is widely referenced 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 actively engages with researchers, regulatory agencies, and industry…
Sex Differences in Clinical Trial Recruiting
The following article investigates several systematic reviews into sex and gender representation in individual clinical trial patient populations. In these studies sex ratios are assessed and evaluated by various factors such as clinical trial phase, disease type under investigation and disease burden in the population. Sex differences in the reporting of safety and efficacy outcomes are also investigated. In many cases safety and efficacy outcomes are pooled, rather than…
Medical Device Categorisation, Classification and Regulation in the United Kingdom (updated for 2026)
Contributor: Sana Shaikh Medical Device Categorisation, Classification and Regulation in the United Kingdom Having a thorough understanding of the classification and class of your medical device is vital for navigating the appropriate regulatory assessment route and achieving market authorisation. While the scope of medical devices is incredibly broad, for regulatory purposes in the UK, they are classified based on device type, duration of use, and level of risk. All…
Regulation of Connected Medical Devices and IOmT
Collection and transmission of personal biologic and health information via IOmT connected medical devices requires regulatory oversight and has cybersecurity implications. Connected medical devices (CMDs) can produce and transmitting patient data, allowing their condition to be monitored by healthcare professionals. They are often used in decentralised clinical trials (DCTs) outside of the clinical trial site, allowing for participants who wouldn’t usually be able to attend. CMDs have led to…
Cybersecurity Considerations for Connected Medical Devices and the “Internet of Medical Things”
Cybersecurity for IOmT connected medical devices. Advancements in technology of the past few decades has led to the development of devices capable of connecting to one another via networks such as Wi-Fi and Bluetooth, allowing them to create, transmit and receive data between one another. Medical technology (Medtech) companies have utilised these features to develop connected medical devices. These devices can transmit patient data such as heart rate, blood…
Medical Device Clinical Trials vs Pharmaceutical Clinical Trials – What’s the Difference?
Medical devices and drugs share the same goal - to safely improve the health of patients. Despite this, substantial differences can be observed between the two. Principally, drugs interact with biochemical pathways in human bodies while medical devices can encompass a wide range of different actions and reactions, for example, heat, radiation (Taylor and Iglesias, 2009). Additionally, medical devices encompass not only therapeutic devices but diagnostic devices, as well…