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The value of registry data in the clinical evaluation of medical devices - Volume 29, Issue

Medical device manufacturers must continuously evaluate all clinical data available for their products marketed in Europe. With the European Medical Device Regulation 2017/745 coming into force in May 2021, manufacturers are required to assess…

Penning hope: The impact of medical writing for rare conditions - Volume 34, Issue

In this article, I explain my route into the world of rare conditions, my experience of working as a clinician, and my passion for raising awareness to all involved. I achieve this by providing education to healthcare professionals, patients, and…

The 3 C’s of medical writing: Communication, conflict management, and critical thinking - Volume 33, Issue

Human-centred “soft” skills are becoming increasingly essential, especially in the current digital workspace. As medical writers navigate the intricate landscape of compliance and precision, they must fortify their soft skills with a foundation of…

Medical writing in Italy in 2024: Results of the first Italian business and compensation survey - Volume 33, Issue

In Italy, little is known about the roles, activities, and compensation of medical writers and scientific communicators. A survey, tailored to local aspects and regulations, was conducted to capture a contemporary snapshot of the medical writing…

Transparency through the lens of data protection and privacy: A clinical research organisation medical writing perspective - Volume 33, Issue

Medical writers maintain a fine balance between data transparency obligations and personal data protection in clinical reports. Hence, we must stay informed of data protection requirements outlined in the EU General Data Protection Regulation (GDPR)…

Origin and development of English for Medical Purposes. Part I: Research on written medical discourse - Volume 23, Issue

In this two-part review, I present the birth and growth of ‘English for Medical Purposes’, a branch of applied linguistics. This first part summarises the research conducted on English-medium written medical discourse, from early register analysis…

The worldwide landscape of freelance medical writing: Exploring challenges and opportunities - Volume 33, Issue

The COVID-19 pandemic has had a significant impact on the pharmaceutical, biotechnology, and life sciences industries, ultimately affecting associated professionals such as freelance medical writers. Throughout this global event and its aftermath,…

Biostatistics and medical writing: Synergy in preparing clinical trials documents - Volume 25, Issue

Biostatisticians and medical writers are among the key people who develop important documents for clinical trials. These documents include clinical study protocols, statistical analysis plans, statistical outputs, and clinical study reports. This…

A beginner´s guide to writing clinical investigation plans and reports for medical devices - Volume 31, Issue

A clinical investigation plan for a medical device must outline and justify all objectives of the clinical investigation, present and justify the investigational design and methodology, and state principal features of the statistical analysis. A…

Charting your way to the top: The 12 major milestones of freelance medical writing - Volume 32, Issue

As a freelance medical writer, it’s tough to know how well you’re doing – conventional career metrics don’t apply and you don’t have a boss keeping tabs on you. Yet, for your medical writing business to stand the test of time, with you at the helm,…

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Scope

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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