Debbie Jordan

Contributions

CORE Reference – a tool for modern clinical study reports in an era of increasing transparency and disclosure - Volume 27, Issue 2

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…

Out on Our Own - Volume 24, Issue 1

With spring comes a renewed sense of optimism. A good time, perhaps, to review where we are in our businesses and consider how we can improve. Michelle Storm Lane of the Association of Independent Professionals and the Self Employed (IPSE) provides…

An overview of the Common Technical Document (CTD) regulatory dossier - Volume 23, Issue 2

The Common Technical Document (CTD) was designed to provide a common format between Europe, USA, and Japan for the technical documentation included in an application for the registration of a human pharmaceutical product. The CTD dossier is divided…

English Grammar and Style - Volume 22, Issue 3

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…

Out On Our Own - Volume 21, Issue 3

Another summer has come and gone. In this issue of OOOO, we are happy to feature Paul Woolley's novel approach of comparing employment and freelancing. I am sure many of us can identify with some of the points he raises. We thank Debbie Jordan for…