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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…
Applications of artificial intelligence (AI)/machine learning (ML) components in drug development are growing exponentially. The trend is expected to continue. The growth has resulted in increased engagements on the part of regulatory agencies to…
For most of us, medical writing is highly technical. We prepare regulatory or clinical documents or write materials targeted to medical doctors. Medical writing for lay audiences is different, and it does not come naturally to most of us because…
Increasing amounts of information are being made available to patients – but how do we know if we are getting it right and meeting people's needs? In this article, we describe how we have employed user testing to test and improve not just…
With the introduction of the new EU Legislation in 2012, RMP requirements have changed significantly, triggering content- and process-related changes. An RMP is written as part of a submission dossier and is submitted for assessment to the EMA. The…
This is a report of our experience with a predatory journal that invited us to join them after having seen our winning essays on how to identify predatory journals. We applied the system we recommended therein to investigate the true nature of the…
Being a mentor or a mentee can be fulfilling and rewarding. In this article, we look at the role and relationship of mentors and mentees, and the importance of using soft skills within the mentor/mentee dynamic. Individually tailored and productive…
Before the European Medical Writers Association (EMWA) and the American Medical Writers Association (AMWA), there was the Mississippi Valley Medical Editors Association (MVMEA). Most medical writers are unaware of the history of MVMEA and of how it…
Embracing artificial intelligence in medical writing: A new era of efficiency and collaboration Authors: Sofie Bergstrand, Catherine Heddle, Montse Sabaté, Marta Mas Section Editor: Nicole Bezuidenhout Artificial intelligence (AI) tools have…
Copyediting is crucial for enhancing the quality and credibility of medical manuscripts in Pakistan. Although English is an official language used in government and education, many researchers are not native speakers, leading to linguistic inaccuraci…
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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