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Writing bioanalytical reports - Volume 23, Issue

Bioanalytical reports are usually written by bioanalysts. Medical writers offer a valuable contribution to bioanalytical reporting, increasing the efficiency of document development and improving the quality of data presentation. This article…

Clinical Evaluation Reports from the medical writer’s perspective! - Volume 26, Issue

Abstract Clinical evaluation is a structured ongoing procedure to collect, appraise and analyse clinical data pertaining to a medical device. The clinical data include current knowledge of the condition to be treated, published literature about the…

The illusion of certainty and the certainty of illusion - Volume 25, Issue

Critical thinking is necessary to edit a scientific article. However, in addition to questions about the language, we can also question the assumptions, documentation, and implications of the research, in a process I call “analytical editing.” A…

Statistical principles in biosimilar development - Volume 28, Issue

Unlike new drug development where superiority over an active comparator or placebo often has to be proven, biosimilar development focuses on showing similarity of the proposed biosimilar to an already approved reference product. This affects…

Someone in your corner: Musings of a mentor and mentee - Volume 30, Issue

What is a modern mentorship, how do you make it work, and what does gardening have to do with it? Let us take you on a tour of the growing garden of our own modern mentorship, showing how we as a medical writer (Lillian Sandø; mentor) and a clinical…

Regulatory Writing - Volume 22, Issue

The European Medicine Agency's draft policy on the publication of clinical trial data for consultation (POLICY/0070, EMA/240810/2013) is causing quite a stir. The draft policy provides for the publication of large parts of the clinical study reports…

EU sourcing requirements for animal-derived materials - Volume 31, Issue

Regenerative medical products derived from animal tissue have been used to successfully treat millions of patients. As they are manufactured from animal sources, there are bio-contamination and biocompatibility risks that must be addressed in…

Good Writing Practice - Volume 26, Issue

Introduction Dissonant nonparallelism occurs in two patterns of comparison: the typical adjective-based pattern (x is similar to y; there is more x than y) and the less common correlative conjunction-based pattern (the more x…the more y). In this…

Good Writing Practice - Volume 28, Issue

Paragraph lengthiness and complexity cause a continuity inexplicity (discontinuity), which can be lessened by using forecasting and backcasting markers of the information pattern. Thus, omission of such continuity markers (e.g., a subheading)…

Regulatory Writing: New developments in public disclosure of clinical trials - Volume 24, Issue

In April this year, the World Health Organisation (WHO) issued a statement on the public disclosure of clinical trial results (the full statement is available from http://www.who.int/ictrp/results/reporting/en/). In essence, this statement…

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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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