In the Bookstores - Volume 26, Issue

What Every Medical Writer Needs to Know: Questions and Answers for the Serious Medical Author They say “don’t judge a book by its cover”, but the title of this book lends itself to curiosity. In What Every Medical Writer Needs to Know, Dr Robert B.…

Regulatory submissions of non-interventional post-authorisation safety studies - Volume 26, Issue

The post-authorisation safety study (PASS) is a pharmacovigilance activity often required as a post-marketing commitment to establish a safety profile or address specific safety concerns. An imposed PASS must be submitted in common technical…

Observations and Observational Studies - Volume 26, Issue

Our publication, Medical Writing, has always been a work in progress, continually evolving to meet our members’ needs and desires. Originally a four-page newsletter called the EMWA Newsletter, it was renamed The Write Stuff in 1998 and, under the…

English Grammar and Style - Volume 23, Issue

Pronouns are useful referents (i.e. the thing doing the referring) to avoid repetition of words (usually nouns). Although personal pronouns (he, she, and I, in particular) are infrequent in medical writing, the neutral ‘it’ and the demonstrative…

Innovative use of master protocols for pivotal studies in rare diseases - Volume 34, Issue

Recent years have seen the development of clinical study protocols that introduce more complex design features into the usual gold-standard randomised controlled trials (RCTs). Complex protocols are potentially useful for drug evaluation in the…

History of biostatistics - Volume 25, Issue

The history of biostatistics could be viewed as an ongoing dialectic between continuity and change. Although statistical methods are used in current clinical studies, there is still ambivalence towards its application when medical practitioners…

Visual aids in patient-focused drug development and routine clinical practice - Volume 34, Issue

Effective medical communication is critical for patient consent, adherence to treatment, and improved health outcomes. Visual aids, such as infographics, diagrams, and charts, have proven invaluable for enhancing comprehension, particularly of…

Post-market clinical follow-up insights - Volume 31, Issue

The EU Medical Devices Regulation (MDR) brought about new post-market clinical follow-up (PMCF) requirements for medical devices. Whereas complaint monitoring and literature searches were often sufficient under the Medical Devices Directives (MDD),…

Study design made easy - Volume 25, Issue

Analysis of statistical data is an important part of any medical writer’s skill set, especially those professionals working in publication and regulatory areas. Under - standing the various study designs is key to a thorough understanding of study…

Regulatory Matters - Volume 30, Issue

Calling all medical writers:

Focus your writing with lean authoring

In today’s medical writing environment, authors are routinely faced with expedited timelines to write documents about highly complex studies with overwhelming amounts of data. Revi…