Type: Publications

WorldPharma-2016 Vol 2
A New Standard for Medical Writing
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...
Author: Sam Hamilton and Julia Forjanic Klapproth
Journal: Clinical Trials Insight
Date: World Pharma 2016 - Vol 2
30_Do you measure up_Julia Forjanic Klapproth_EPC_May 2016_Thumbnail
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. While medical writing...
Author: Julia Forjanic Klapproth
Journal: International Clinical Trials, ICT / European Pharmaceutical Contractor, EPC
Date: May 2016
29_Back to the future_Douglas Fiebig_MEW 24-3_Sep 2015_Thumbnail
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
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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. Perhaps it is time to move away from this...
Author: Barry Drees
Journal: European Pharmaceutical Contractor, EPC
Date: September 2015
Successfully outsourcing medical writing_Julia Forjanic Klapproth_MEW 24-3_Sep 2015_Thumbnail
Successfully outsourcing medical writing
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...
Author: Julia Forjanic Klapproth
Journal: Medical Writing, the journal of EMWA
Date: Vol.24, No.3, September 2015
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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...
Author: Massoud Toussi, Lisa Chamberlain James and Sir Alasdair Breckenridge
Journal: Medical Writing, the journal of EMWA
Date: Vol.24, No.2, June 2015
22_Strategic medical writing in the post-authorisation phase_Sarah Richardson_MEW 23-4_Dec 2014_Thumbnail
Strategic Medical Writing in the Post-Authorisation Phase
The latest legislation for the most common post-authorisation documents (RMP, PSUR, safety studies).
Author: Sarah Richardson
Journal: Medical Writing, The journal of EMWA
Date: Vol.23, No.4, December 2014
18_Battling with clinical submissions_Julia Forjanic Klapproth_The Write Stuff 15-1_2006_Thumbnail
Battling with clinical submissions: War rooms and other tricks of the trade
Submission dossiers - the most interesting and challenging documents for a medical writer.
Author: Julia Forjanic Klapproth
Journal: The Write Stuff, The journal of EMWA
Date: Vol.15, No.1, 2006
14_The Investigator's Brochure_A multidisciplinary document_Douglas Fiebig_MEW 23-2_Jun 2014_Thumbnail
The Investigator's Brochure - A multidisciplinary document
The Investigator's Brochure (IB) B is primarily written to enable investigators to assess risks and benefits.
Author: Douglas Fiebig
Journal: Medical Writing, The journal of EMWA
Date: Vol.23, No.2, June 2014
12_Words of Wisdom-Protocol Writing_Julia Forjanic Klapproth_ICT_Aug 2013_Thumbnail
Words of Wisdom: writing Protocols
The ABCs of writing effective Clinical Study Protocols
Author: Julia Forjanic Klapproth
Journal: International Clinical Trials, ICT
Date: August 2013
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Under the Hammer
Inappropriate use of reverse auctions puts suppliers at an unfair loss and disadvantages buyers.
Author: Julia Forjanic Klapproth & Douglas Fiebig
Journal: European Pharmaceutical Contractor, EPC
Date: September 2014
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Strategic Benefits
Medical writing helps communicate key messages and makes sure teams stay focused on a common goal.
Author: Julia Forjanic Klapproth
Journal: International Clinical Trials, ICT
Date: November 2011
10_Reverse auctions - the perfect folly for sourcing clinical services_Julia Forjanic Klapproth & Douglas Fiebig_MEW_23_3_Sep 2014_Thumbnail
Reverse auctions: the perfect folly for sourcing clinical research services
Are reverse auctions (e-auctions) between suppliers of services as good as sometimes claimed?
Author: Julia Forjanic klapproth and Douglas Fiebig
Journal: Medical Writing, The journal of EMWA
Date: Vol.23, No.3, September 2014
16_Risk Management Plans_New challenges for a new era_Lisa Chamberlain James et al_TOPRA 11-6_Jun 2014_Thumbnail
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.
Author: Lisa Chamberlain James, Lambert A.J.M. Creuwels and Madhu Davies
Journal: TOPRA - Regulatory Rapporteur
Date: Vol.11, No.6, June 2014
21_Using Questionnaires in Clinical Research_Thomas Wagner_JCS 6-1_2014_Thumbnail
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.
Author: Thomas Wagner
Journal: Journal for Clinical Studies
Date: Vol.6, No.1, 2014
15_Improving Transparency and Benefit-Risk Assessments with the New RMP_Julia Forjanic Klapproth & Lisa Chamberlain James_JCS 5-5_2013_Thumnail
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.
Author: Julia Forjanic Klapproth and Lisa Chamberlain James
Journal: Journal for Clinical Studies
Date: Vol.5, No.5, 2013
25_Mind the Gap_Patient Information_Lisa Chamberlain James_EPC_Mar 2013_Thumbnail
Mind the Gap
Why the move for more and better patient information is gathering momentum.
Author: Lisa Chamberlain James
Journal: European Pharmaceutical Contractor, EPC
Date: March 2013
24_Communicating with Patients-Common Sense or a Black Art_Lisa Chamberlain James_JPC 2-3_Sep 2012_Thumbnail
Communicating with Patients - Common Sense or a "Black Art"?
Good patient information maximises the benefits and intended use of a medicine.
Author: Lisa Chamberlain James
Journal: Journal for Patient Compliance
Date: Vol.2, No.3, 2012
23_The Art of Communication-Patient Information_Lisa Chamberlain James_EPC_Sep 2012_Thumbnail
The Art of Communication
Poor patient information can lead to low recruitment, low compliance and incorrect medicine usage.
Author: Lisa Chamberlain James
Journal: European Pharmaceutical Contractor, EPC
Date: September 2012
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Planting the Seed: Post-Marketing Research
The importance of good planning and communication for the success of postmarketing research.
Author: Thomas Wagner
Journal: International Clinical Trials, ICT
Date: May 2012