Category: Pharma & Drug Development

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…

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…

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…

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…