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Many pharmaceutical and medical device companies are making huge environmental, social, and governance (ESG) commitments, such as striving to achieve carbon neutrality, and aiming to reach diversity, equity, and inclusion (DEI) goals. In order to…
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…
Reviews provide a synthesis of published literature on a topic and describe its current state-of-art. Reviews in clinical research are thus useful when designing studies or developing practice guidelines. The two standard types of reviews are (a)…
Hello, medical device fans! Social media is increasingly integrated into all aspects of our daily lives, even for many of you non-digital natives (myself included). In this issue, we look at how the medical device industry is beginning to utilise…
Editorial Welcome readers, I’ve lost count how many times people ask me, what is a medical writer? And it isn’t just my mum and aunt who ask me such a question; medical doctors, PhD students, and academic professors are often surprised that…
No setback comes without a blessing Like many things in the professional world, I got to know more about medical writing and see it as the next step in my professional life, thanks to a connection. A friend of a friend was a native Spanish speaker…
Background: The European Union Clinical Trials Regulation 536/2014 (EU CTR) requires sponsors to submit summaries of clinical trial results in plain/lay language (Plain Language Trial Summaries [PLTS]). A multidisciplinary working group developed…
“For many people, the internet can feel like a lonely place. It can feel like… a big, endless, expansive void where you can constantly call out to it but no one’s ever listening. But… I found, in sharing my feelings with the void, event…
Section Editor: Evguenia Alechine I’m glad to be sharing the work of a rising star in the medical writing and science communication world. On this occasion, I had the pleasure of working with Valentina Torres Monserrat, who has a degree in…
It’s been more than 6 years since our last Medical Writing edition dedicated to clinical trial transparency and disclosure. Since then, we have seen the full implementation of the long-awaited EU Clinical Trials Regulation (CTR), the pause and restar…
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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