Document management systems for medical writing - Volume 28, Issue

Clinical trial data are rightfully protected by robust regulations; given these requirements and increasing demands from clients, a validated and compliant electronic document management system is now a necessity for established medical writing…

Editing for writers who have English as an additional language - Volume 27, Issue

Editors of English are typically met with expectations to make a quick fix of documents that need more radical changes than authors think. As editors, we should convey how we work to improve readability, and either adjustor gain acceptance for our…

Mentor vs. line manager: Differences and similarities - Volume 30, Issue

A good mentor may be a good line manager in a business setting and vice versa, but there are some key differences: mentors are more skill-oriented, while line managers are more goal-oriented. People who are both good line managers and mentors are…

Medical writing in China: Trends and opportunities - Volume 27, Issue

The Chinese pharmaceutical regulatory landscape and medical publication policies have gone through drastic changes in recent years, and they continue to evolve. These changes provide great opportunities and many challenges to medical writers in…

Regulatory Matters - Volume 26, Issue

Medical writers are often involved in the preparation of submission documents such as clinical overviews and clinical summaries. The submission of the application (or, in the case of drugs already approved, a variation or supplement) is an important…

A guide to pre-approval regulatory documents - Volume 23, Issue

Measuring health outcomes: The foundation of contemporary healthcare decision-making - Volume 27, Issue

Healthcare professionals and patients are (or should be) interested in understanding the benefits of health care. We should be able to know the expected treatment benefits and to see quantifiable evidence that supports those expectations. Such…

Regulatory pathways for development and submission activities - Volume 28, Issue

This article discusses how different regulatory requirements for a dossier requesting marketing authorisation for a medical drug affect the deliverables from development functions and the submission groups including medical writing. The content of…

Some considerations on the safety evaluation section of clinical study reports for studies with anticancer drugs - Volume 21, Issue

The International Conference on Harmonisation (ICH) guideline E3 describes the structure and content of clinical study reports (CSRs). However, this standard structure should be interpreted according to the type of study and data, including…

Working with authors to develop high-quality, ethical clinical manuscripts: Guidance for the professional medical writer - Volume 23, Issue

One measure of career success for clinical researchers is reporting their findings in a peer-reviewed journal. Writing a clinical manuscript that has impact and relevance to their intended audience is crucial for publication success. However,…