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Medical writing teams are crucial in the pharmaceutical industry at every stage of drug development. With growing regulatory pressure and shrinking profit margins, outsourcing these activities is considered a viable option that provides multiple…
Economic liberalisation has led to an influx of clinical research and a boom in the medical writing industry in India. Medical writers in India at present contribute mostly to medical communications, health journalism, and academic medical…
A large proportion of medical writing activities are now outsourced. This means the need for medical writing service providers is growing, and with increased demand there comes an increased supply of providers. The challenge that arises in such a…
Drug development forms the core of the pharmaceutical industry. Medical writing is a key function in pharmaceutical companies and clinical research organisations that works on scientific publications and regulatory dossiers. Regulatory writing…
Using an outline to organize your writing project can help keep you on a straight path and avoid wandering into wastelands of irrelevance. There are various formats – the classic hierarchal model, the IMRAD system used for research reports, the…
The European General Data Protection Regulation 2016/ 679 (GDPR) aims to ensure the security and privacy of individuals in the European Union (EU). Companies located within and outside of the EU must comply with GDPR when processing personal data…
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)…
Major clinical research funders are increasingly adopting policies supporting or mandating data sharing. These moves should improve the transparency and availability of clinical trial data and are likely to impact the work and responsibilities of…
International Conference on Harmonisation (ICH) E6 and ICH E3, developed nearly 20 years ago, are the current regulatory guidance documents for developing clinical study protocols (CSPs) and clinical study reports (CSRs). Ambiguity in the…
‘Why write a clinical study report (CSR)? What are the guidance documents? Can I interpret them? Can I deliver my CSR on time?’ This article addresses these questions – and others, provides a companion guide to CSR authoring for preregistration drug…
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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