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Titles of clinical trials may directly influence whether patients, caretakers, or healthcare professionals will want to obtain more information about the trial. Major clinical trial registries require lay titles (referred to as “brief” or “public”…
Automation and artificial intelligence (AI) are useful tools that are rapidly progressing in many fields within the clinical trial landscape, and their use in the production of narratives for clinical study reports is no exception. Technology and…
Good patient education supports improved outcomes and an efficient, cost-effective healthcare system. In the highly regulated, fast-paced pharmaceutical industry, the challenges that medical writers face in writing for patients are multi-fold.…
Developing drugs for cancer is a process as complex as the disease itself. At the planning stage of a clinical trial for an oncology drug, thorough and careful consideration must be given to choosing the right study design and endpoints/estimands,…
Designing clinical trials in rare diseases comes with a specific set of challenges including limited knowledge around the natural history of a disease, small sample size available for trial participation, regulatory guidance that is not calibrated…
In this article, I summarise how, as a medical writer with over 20 years of experience in regulatory writing, all with a contract research organisation, I transitioned into the world of disclosure and how I now have my feet firmly in both camps:…
Switzerland is practically unknown in the drug/medical device regulatory landscape despite being home to some of the world's biggest pharmaceutical firms. This article briefly describes the regulations governing clinical trials in Switzerland and…
This article explores the role of translation and translators within the process of test adaptation. With similarities to the linguistic validation process in clinical research, test adaptation is a complex multistep and iterative process in which…
In this release of My First Medical Writing, I have the pleasure to share great articles written by two aspiring medical writers. Nesrine Benhizia-Benaouicha, MD, is a clinical trial manager and academic medical writer at the emergency department in…
Current practice requires clinical and regulatory documents to be created and updated manually by medical writers throughout a product’s development. Conventionally, document content is unstructured, with freeform text, figures, and tables that the…
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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