Regulatory submissions of non-interventional post-authorisation safety studies: Challenges for data interpretation and comparisons with clinical data
The post-authorisation safety study (PASS) is a pharmacovigilance activity often required as a post-marketing commitment to establish a safety profile or address specific safety concerns. An imposed PASS must be...
Julia Forjanic Klapproth, co-founder of Trilogy Writing & Consulting, explains how to prepare good requests for information and proposals in the field of medical writing. If you have ever been...
The Pharmacovigilance Medical Writer: Medical Writer, Project Manager, Regulatory Expert
Pharmacovigilance is a critical element of drug development and marketing. The evaluation and monitoring of patient safety and a drug’s benefit/risk is a highly regulated global task, which is required...
The Challenge of CTD Submissions and Responding to Questions from the Authorities
The Common Technical Document is an international standard for the summary documents needed to obtain regulatory approval of medicinal products. These summary documents involve presenting key information drawn from a...
Medical Writing: The Backbone of Clinical Development
This special edition is meant to increase the general awareness of the need for good documentation on the one hand and to provide good medical writing practices and tricks of the trade on the other hand. It is intended to have lasting value as a reference book for the target audience – medical writers and everyone in the pharmaceutical industry working with medical writers.
Journal: Special Edition of International Clinical Trials, ICT
Date: February 2017
Streamlining Clinical Study Protocols and Reports
Recent pharma initiatives have been established to help ensure that clinical study protocols and reports are always presented in a similar way, making for easier assimilation and assessment. This article...
What you Need and When – The Key Documents in the Drug Lifecycle
Clinical development is a complex and expensive undertaking, involving many years of research that culminate with clinical trials, the objectives and results of which all have to be documented. This...
Discrepancies in the ways in which the documentation for clinical drug development is structured and presented have hampered understanding and progress for decades. Medical writing consultant Sam Hamilton and Trilogy...
For any service, the end user wants a way to measure the performance of the service provider to understand if they are getting good value for money. While medical writing...
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....
Nowadays it appears that scientists are working under the misguided assumption that data presentation must showcase the complexities experienced during research. Perhaps it is time to move away from this...
A large proportion of medical writing activities are now outsourced. This means the need for medical writing service providers is growing, and with increased demand there comes an increased supply...
Using social media as the patient's voice in the benefit-risk assessment of drugs: Are we ready?
There is no doubt that the public interest in healthcare-related issues is growing. This, coupled with the surge in the use of social media, leaves the pharmaceutical industry with a...
