A Special Edition

Medical Writing: The Backbone of Clinical Development

In the end of 2016, experts from the world of medical writing were brought together to support an industry-wider initiative – a special edition magazine on Medical Writing.

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JournalSpecial Edition of International Clinical Trials, ICT
Volume/YearFebruary 2017
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Competencies: The Value and Qualities of Good Medical Writers

Back to the future… or the amazing lack of progress in effective document review

However experienced you are, and whatever ‘level’ medical writer you may be, we all share the same pain… document review processes.

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AuthorDouglas Fiebig
JournalMedical Writing, the journal of EMWA
Volume/YearVol. 24, No. 3, September 2015
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Lost in Translation

Nowadays it appears that scientists are working under the misguided assumption that data presentation must showcase the complexities experienced during research.

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AuthorBarry Drees
JournalEuropean Pharmaceutical Contractor, EPC
Volume/YearSeptember 2015
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Strategic Benefits

Medical writing helps communicate key messages and makes sure teams stay focused on a common goal.

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AuthorJulia Forjanic Klapproth
JournalInternational Clinical Trials, ICT
Volume/YearNovember 2011
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Strategic Medical Writing: why settle for less?

Good medical writers serve as communication specialists and advisors on getting your message across.

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AuthorJulia Forjanic Klapproth
JournalBrAPP, British Association of Pharmaceutical Physicians
Volume/YearVol.22, No.6, May 2012
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AuthorJulia Forjanic Klapproth and Barry Drees
JournalInternational Clinical Trials, ICT
Volume/YearMay 2010
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European Medical Writers Association (EMWA)

The history of The Write Stuff: 10 years of bringing European medical writers together

Barry Drees reflects on 10 years as editor of the journal of European Medical Writers Association.

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AuthorBarry Drees
JournalThe Write Stuff, The journal of EMWA
Volume/YearVol.17, No.1, 2008
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Outsourcing Medical Writing

Successfully outsourcing medical writing

ABSTRACT 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 of providers.

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AuthorJulia Forjanic Klapproth
JournalMedical Writing, the journal of EMWA
Volume/YearVol.24, No.3, September 2015
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Under the Hammer

Inappropriate use of reverse auctions puts suppliers at an unfair loss and disadvantages buyers.

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AuthorJulia Forjanic Klapproth & Douglas Fiebig
JournalEuropean Pharmaceutical Contractor, EPC
Volume/YearSeptember 2014
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Reverse auctions: the perfect folly for sourcing clinical research services

Are reverse auctions (e-auctions) between suppliers of services as good as sometimes claimed?

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AuthorJulia Forjanic klapproth and Douglas Fiebig
JournalMedical Writing, The journal of EMWA
Volume/YearVol.23, No.3, September 2014
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Cutting Back: solutions to reduce the time and costs of clinical development

Outsourcing and Functional Service Provision (FSP) of medical writing

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AuthorJulia Forjanic Klapproth
JournalInternational Clinical Trials, ICT
Volume/YearNovember 2009
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Medical Writing: Outsourcing Guide

What and when to outsource, how to find a medical writing partner.

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AuthorJulia Forjanic Klapproth
JournalEuropean Pharmaceutical Contractor, EPC
Volume/YearDecember 2010
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Patient Information and Educating the Lay Reader

Mind the Gap

Why the move for more and better patient information is gathering momentum.

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AuthorLisa Chamberlain James
JournalEuropean Pharmaceutical Contractor, EPC
Volume/YearMarch 2013
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Communicating with Patients – Common Sense or a “Black Art”?

Good patient information maximises the benefits and intended use of a medicine.

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AuthorLisa Chamberlain James
JournalJournal for Patient Compliance
Volume/YearVol.2, No.3, 2012
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The Art of Communication

Poor patient information can lead to low recruitment, low compliance and incorrect medicine usage.

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AuthorLisa Chamberlain James
JournalEuropean Pharmaceutical Contractor, EPC
Volume/YearSeptember 2012
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Pharmacovigilance and Product Safety

Using social media as the patient’s voice in the benefit-risk assessment of drugs: Are we ready?

ABSTRACT 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 set of unique opportunities and challenges.

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AuthorMassoud Toussi, Lisa Chamberlain James and Sir Alasdair Breckenridge
JournalMedical Writing, the journal of EMWA
Volume/YearVol.24, No.2, June 2015
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Strategic Medical Writing in the Post-Authorisation Phase

The latest legislation for the most common post-authorisation documents (RMP, PSUR, safety studies).

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AuthorSarah Richardson
JournalMedical Writing, The journal of EMWA
Volume/YearVol.23, No.4, December 2014
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Postmarketing Clinical Research

Using Questionnaires in Clinical Research – A Guide through the Data Jungle

Emphasis is growing on quality of life, treatment costs, real-life effectiveness and patient outcomes.

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AuthorThomas Wagner
JournalJournal for Clinical Studies
Volume/YearVol.6, No.1, 2014
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Planting the Seed

The importance of good planning and communication for the success of postmarketing research.

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AuthorThomas Wagner
JournalInternational Clinical Trials, ICT
Volume/YearMay 2012
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Regulatory Submissions and Authority Questions

Battling with clinical submissions: War rooms and other tricks of the trade

Submission dossiers – the most interesting and challenging documents for a medical writer.

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AuthorJulia Forjanic Klapproth
JournalThe Write Stuff, The journal of EMWA
Volume/YearVol.15, No.1, 2006
Download as PDF  (40 KB)

Finding the Answers

Responding to authority questions – how medical writers can streamline the relay race.

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AuthorJulia Forjanic Klapproth
JournalEuropean Pharmaceutical Contractor, EPC
Volume/YearMarch 2012
Download as PDF  (632 KB)

The Clinical Study Protocol (CSP)

Words of Wisdom: writing Protocols

The ABCs of writing effective Clinical Study Protocols

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AuthorJulia Forjanic Klapproth
JournalInternational Clinical Trials, ICT
Volume/YearAugust 2013
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The Importance of Good Communication and Documentation

Do You Measure Up?

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.

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AuthorJulia Forjanic Klapproth
JournalInternational Clinical Trials, ICT / European Pharmaceutical Contractor, EPC
Volume/YearMay 2016
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Medical Writing in the Old World

Although there has been what amounts to medical writing here for a long time, it is a relatively new concept as a specialized profession.

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AuthorBarry Drees
JournalThe Write Stuff, The journal of EMWA
Volume/YearVol.8, No.3, 1999
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The Investigator’s Brochure (IB)

The Investigator’s Brochure – A multidisciplinary document

The Investigator’s Brochure (IB) B is primarily written to enable investigators to assess risks and benefits.

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AuthorDouglas Fiebig
JournalMedical Writing, The journal of EMWA
Volume/YearVol.23, No.2, June 2014
Download as PDF  (79 KB)

Regulatory Questions and Answers: The Investigator’s Brochure

Advice on the appropriate format for the Investigator’s Brochure.

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AuthorDouglas Fiebig
JournalThe Write Stuff, The journal of EMWA
Volume/YearVol.9, No.3, 2000
Download as PDF  (27 KB)

The Paediatric Investigation Plan (PIP)

Medicines for Children

Preparing the Paediatric Investigation Plan (PIP) application.

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AuthorDouglas Fiebig
JournalInternational Clinical Trails, ICT
Volume/YearMay 2011
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The Risk Management Plan (RMP)

Risk Management Plans – New challenges for a new era

The complexity of the new RMP, not least the summary for the lay reader, is challenging writers.

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AuthorLisa Chamberlain James, Lambert A.J.M. Creuwels and Madhu Davies
JournalTOPRA - Regulatory Rapporteur
Volume/YearVol.11, No.6, June 2014
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Improving Transparency and Benefit/Risk Assessments with the New Risk Management Plan

Personalised health care – “shared decision-making” with patients relies on them being well informed.

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AuthorJulia Forjanic Klapproth and Lisa Chamberlain James
JournalJournal for Clinical Studies
Volume/YearVol.5, No.5, 2013
Download as PDF  (112 KB)