Overcoming confidential information challenges faced by study sponsors today - Volume 32, Issue

As health authorities aim to increase clinical trial transparency and visibility to the public, pharmaceutical manufacturers are facing new pressure points. New regulations require the disclosure of clinical trial application data, many of which cont…

Regulatory Matters - Volume 33, Issue

Section Editors: Clare Chang, Zuo Yen Lee In regulatory submission writing, a project facilitator is the yin to a medical writer’s yang Authors: Yoko Komatsuzaki, Julia Forjanic Klapproth Authoring and reviewing complex, parallel regulatory…

Using social media as the patient's voice in the benefit-risk assessment of drugs: Are we ready? - Volume 24, Issue

There is no doubt that the public interest in healthcare-related issues is growing. This, coupled with the surge in the use of social media, leaves the pharmaceutical industry with a set of unique opportunities and challenges. The screening and…

Registration and ethics committee approval for observational studies: Current status and way forward - Volume 26, Issue

Randomised controlled trials (RCTs) have always been recognised as the highest level of evidence in medical research. However, they cannot address the questions that one comes across in real-world clinical practice. Observational studies can answer…

Biostatistics, data management, and medical writing: A multidisciplinary approach to the development of the CTD integrated summaries - Volume 29, Issue

Analyses of integrated databases of efficacy and safety are a Food and Drug Administration (FDA) requirement. They are very useful in evaluating the safety and efficacy data gathered in multiple clinical studies. However, their utility is dependent…

Out On Our Own - Volume 23, Issue

Out On Our Own - Volume 22, Issue

Editorial We hope that you enjoyed the summer months and found time to step away from your desks and relax. This time last year, Kath organised her first ‘Medical Writers’ Retreat’, the aim of which was to provide an opportunity for fellow…

Editorial - Volume 33, Issue

Medical writing transcends borders, uniting professionals across geographies, demographics, languages, and cultures. This inherent global perspective has inspired the theme for this issue. While previous editions have explored medical writing in…

Message from the President - Volume 21, Issue

Dear Medical Writers Top of Form Bottom of Form I expect I am not the only one who at this time of year looks at their calendar in disbelief and asks how on earth another 12 months can have disappeared so quickly? The end of the year is always an…

EMWA News - Volume 28, Issue

On July 29, EMWA, together with the American Medical Writers Association (AMWA) and the International Society for Medical Publication Professionals (ISMPP), issued a joint position statement on the dangers of predatory publishing (see p. 34 of this…