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This article focuses on the medical device specific aspects of clinical investigations and does not aim to be a comprehensive introduction to clinical trials. We highlight the key differences to clinical studies of medicinal products in the…
Clinical study reports (CSR) are detailed documents that provide a comprehensive and transparent account of the conduct and results of a clinical trial. They are an important source of information for the regulatory authorities, healthcare…
Amidst the dynamic landscape of pharma - covigilance legislation, medical writers have been gaining increased visibility and importance beyond what had been their traditional role of coordinating and facil it - ating the development of risk…
Medical writing demands a comprehensive set of technical skills, from mastering regulatory and ethical guidelines to honing exceptional writing abilities. The foundation of superior medical writing is built on the hard skills acquired through educati…
The complexities associated with clinical trials for (ultra) rare diseases include regulatory and logistical hurdles and the challenge of building trusting relationships with health authorities, patients, and clinicians. Significant obstacles…
Whether you’re an early adopter, an occasional user, or yet to acknowledge its transformative potential, artificial intelligence (AI) – specifically generative AI applications underpinned by large language models – is undeniably shaping our present…
Model-informed drug development (MIDD) approaches maximise and connect information obtained on a drug during development, allowing better characterisation of its risk: benefit profile. MIDD is especially useful for rare diseases with few patients to…
Medical Writing is a quarterly publication that aims to educate and inform medical writers in Europe and beyond. Each issue focuses on a specific theme, and all issues include feature articles and regular columns on topics relevant to the practice of medical writing. We welcome articles providing practical advice to medical writers; guidelines and reviews/summaries/updates of guidelines published elsewhere; original research; opinion pieces; interviews; and review articles.
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