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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…
I am the founder and managing director of Scinopsis, a medical writing company based in France. Scinopsis is specialised in providing regulatory documents and medical communications to the pharmaceutical, biotechnology, and medical device…
Unlike medical writing, ‘veterinary writing’ does not exist as a defined career path. However, writers are inevitably also required in this field and play important roles in different areas of the veterinary profession for creation of scientific…
AbstractIncreased transparency is one of the provisions of the Clinical Trial and Medical Device Regulations. This article discusses the impact of transparency and disclosure on medical devices. Many modern-day medical devices are software-driven.…
Introducing the Medical Communication section: The wild side of medical writing! Hello and welcome to a brand spanking new section of Medical Writing. When the Editor of Medical Writing, Phil Leventhal, approached me to create a new section,…
We have three articles in this edition. Pamela Haendler's contribution deals with the medical writer as a reviewer and quality checker. Because of their close involvement with all of the documentation on a project, the medical writers involved are…
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…
In a follow-up to the excellent article from Douglas Fiebig on how to use your review cycle effectively, this issue presents an extremely insightful article from Diana Radovan on how to help reviewers to communicate better with writers. Diana…
Preclinical studies –is animal testing necessary?The drug regulatory authorities require testing in animals, to be exact in at least two mammalian species, before the first-in-human trials can be approved. Common criticism is that the results from…
Time, quality, and accuracy are of the essence for expeditious global regulatory submissions. An around-the-clock, 24/7, global medical writing model has been developed that allows efficient development of high-quality documents with appreciable…
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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