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An expanding need for clinical documentation and regulatory health authority interactions during drug development has drawn increased attention to the role of the regulatory medical writer. This role is frequently misunderstood and poorly…
Laura C Collada Ali wears different hats: she is a medical writer plus a medical translator, and has extensive experience delivering multilingual authoring and translation services across a wide range of independent research organisations. She is a…
Medical writers, document quality reviewers, and document specialists work together to produce high-quality clinical and regulatory documents. Cross-functional collaboration with other functional leads like bio statisticians, medical monitors, and…
From scurvy to Covid-19: The role of clinical trials, and medical writing’s crucial role in the process The medical writing community is intrinsically involved in regulatory documentation that spans the entire timeline of clinical research – from…
The clinical research transparency journey Medical Writing. 2024;33(3):6–7. https://doi.org/10.56012/djjd9152
Patient and public involvement and engagement (PPIE) in clinical trial design, conduct, and reporting provides an opportunity for patients and members of the public to provide input on what is important to them. This supports patient-centric trial…
Research on psychotropics is gaining more popularity worldwide and support from drug regulatory agencies, which recognise the unmet medical needs of certain patient communities, such as patients with mental disorders and patients with cancer who…
EditorialSection Editor: Kimi Uegaki Growing and nurturing a grassroots sustainability team in a clinical centre Authors: Sarah Kabani, Virginie Chasseigne, Sihame Chkair Medical Writing. 2023;32(4):87–89. https://doi.org/10.56012/wynp1520
Section Editors: Clare Chang, Zuo Yen Lee Briefing documents: Facilitating health authority interactions Author: Clare Chang Briefing documents, essential for facilitating interactions between pharmaceutical companies and health authorities…
Editorial Sam Hamilton (author and section editor) Medical Writing. 2023;32(3):91–95. https://doi.org/10.56012/hnnl8161 Clinical Data Publication (Policy 0070) relaunch Alison McIntosh (author) In preparation for the relaunch of EMA Clinical…
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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