Journal Watch - Volume 21, Issue

Readability of informed consent forms, sponsor participation in industry trials, and conflict of interest disclosure. Informed consent is a crucial feature of clinical research trials. Guidelines on developing an informed consent form urge writers…

CORE Reference – a tool for modern clinical study reports in an era of increasing transparency and disclosure - Volume 27, Issue

CORE Reference (www.core-reference.org) facilitates the authoring of a content-driven clinical study report (CSR) that is as “public disclosure-ready” as possible. It has potential to increase the quality of final CSRs and enhance consistency within…

English Grammar and Style - Volume 22, Issue

We have three articles in this edition. Pamela Haendler's contribution deals with the medical writer as a reviewer and quality checker. Because of their close involvement with all of the documentation on a project, the medical writers involved are…

Manuscript Writing - Volume 22, Issue

As a medical writer, can or should I be listed as an author of an article? For manuscripts, medical writers often go far beyond providing basic services and therefore may feel entitled to authorship. Medical writers are often the main force behind…

Early benefit assessment of new drugs: The impact on healthcare in Germany - Volume 30, Issue

The early benefit assessment of new drugs was introduced in Germany in 2011. The main rationale was to support pricing negotiations between the statutory health insurance (SHI) system and the pharmaceutical industry. The early benefit assessment…

Veterinary sustainability - Volume 31, Issue

Respected for their knowledge of animal health and disease, veterinarians safeguard animal health and welfare and, where applicable, the productivity of animals under their care. With the threats posed by climate change, the veterinary profession…

A beginner´s guide to writing clinical investigation plans and reports for medical devices - Volume 31, Issue

A clinical investigation plan for a medical device must outline and justify all objectives of the clinical investigation, present and justify the investigational design and methodology, and state principal features of  the statistical analysis. A…

Enabling people with disabilities: Creating accessible electronic documents - Volume 31, Issue

Rather than equating disability with personal identity, we can better understand disability as the consequence of disabling environments. This alternative view suggests that changing the environment can enable people with sensory, motor, and…

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

Pharmaceutical medical writing competencies: Comparing self-perception with employers' expectations - Volume 21, Issue

In the recently published ‘Pharmaceutical Medical Writing Competency Model’, a group of medical writers describes the knowledge, skills, and behaviours they considered essential for successful medical writers. Thus, this model represents a list of…