This article, published in Medical Writing (MEW) journal in June 2014 (Hamilton S. Effective authoring of clinical study reports: A companion guide. MEW 2014;23(2):86-92) provides a companion guide to CSR authoring for preregistration drug trials intended for regulatory submission in the EU, provides links to applicable regulatory guidance documents, and offers experience-based insights. It also presents data sourced from industry professionals over the period 2008-2013 on reporting timelines. HamiltonS_MEW2014_23(2)-CSRCompanionGuide

I am a freelance medical writer providing a range of writing services, primarily to the pharmaceutical industry. I am a post-doctoral virologist working in clinical research since 1994, and specialising in regulatory medical writing from 1999. In my last salaried position (to September 2006), I managed UK Medical Writing for the world’s fifth largest Contract Research Organisation.

I have contributed widely to the official publications (The Write Stuff and Medical Writing [journal]) of the European Medical Writers Association (EMWA). I post my articles on my blog, primarily to disseminate the information to a wider audience, and to hopefully generate some stimulating debate. If you have anything to share, I would love to hear from you.

If you like what you read, and require the services of a highly motivated, experienced and diligent medical writer, then please contact me through my website: https://www.samhamiltonmwservices.co.uk

Sam Hamilton, PhD.