Topic: Document Review & QC
Podcasts
Episode 4: The Power of Good Review Practice
In this episode, Julia and Barry, Senior Partners at Trilogy Writing & Consulting, call for a “revolution and complete overhaul in the way documents are reviewed”. They explain how a focused review process leads to a transformational change in how drugs get approved.
Publications
Help Reviewers Tell You What They Want
Reviewers of regulatory documents need to ensure that their comments are specific, actionable, and relevant, so that no critical time is spent unnecessarily throughout the document development process. Review is...
Author: Diana Radovan
Journal: Medical Writing Special Edition No. 2
Date: February 2020
Help Reviewers Tell You What They Want
Review is an integral part of the medical writing process and relies on clear communication between the medical writer and the reviewer(s). This is a two-way street. Review can be...
Author: Diana Radovan
Journal: Medical Writing, the journal of EMWA
Date: Vol. 27 No. 4, December 2018
Getting the most out of quality control specialists: Practical guidance for medical writers
Quality control (QC) is a process that usually occurs when a document is in a near-final or final state. It involves the checking of documents by QC specialists against source...
Author: Claire Jones
Journal: Medical Writing, the journal of EMWA
Date: Vol. 27, No.3, September 2018
Back to the future... or the amazing lack of progress in effective document review
In 1999, as a still relatively inexperienced medical writer, I was introduced to some software that was going to revolutionise document preparation: Documentum, a collaborative reviewing tool for regulatory documents....
Author: Douglas Fiebig
Journal: Medical Writing, the journal of EMWA
Date: Vol. 24, No. 3, September 2015