Type: Publications

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
20_Planting the Seed_Post-Marketing Research_Thomas Wagner_ICT_May 2012_Thumbnail
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
19_Finding the Answers_Julia Forjanic Klapproth_EPC_mar 2012_Thumbnail
Finding the Answers
Responding to authority questions - how medical writers can streamline the relay race.
Author: Julia Forjanic Klapproth
Journal: European Pharmaceutical Contractor, EPC
Date: March 2012
00 Cover June
Strategic Medical Writing: why settle for less?
Good medical writers serve as communication specialists and advisors on getting your message across.
Author: Julia Forjanic Klapproth
Journal: BrAPP, British Association of Pharmaceutical Physicians
Date: Vol.22, No.6, May 2012
17_Medicines for Children_Douglas Fiebig_ICT_may 2011_Thumbnail
Medicines for Children
Preparing the Paediatric Investigation Plan (PIP) application.
Author: Douglas Fiebig
Journal: International Clinical Trails, ICT
Date: May 2011
08_Cutting Back_Julia Forjanic Klapproth_ICT_Nov 2009_Thumbnail
Cutting Back: solutions to reduce the time and costs of clinical development
Outsourcing and Functional Service Provision (FSP) of medical writing
Author: Julia Forjanic Klapproth
Journal: International Clinical Trials, ICT
Date: November 2009
13_The Investigator's Brochure_Douglas Fiebig_The Write Stuff 9-3_2000_Thumbnail
Regulatory Questions and Answers: The Investigator's Brochure
Advice on the appropriate format for the Investigator's Brochure.
Author: Douglas Fiebig
Journal: The Write Stuff, The journal of EMWA
Date: Vol.9, No.3, 2000
9_epc_Dez10SML
Medical Writing: Outsourcing Guide
What and when to outsource, how to find a medical writing partner.
Author: Julia Forjanic Klapproth
Journal: European Pharmaceutical Contractor, EPC
Date: December 2010
03_The New Documentation Paradigm_Julia Forjanic Klapproth & Barry Drees_ICT_May 2010_Thumbnail
The New Documentation Paradigm – the evolution of medical writing into a strategic function
The evolution of medical writing into a strategic function.
Author: Julia Forjanic Klapproth and Barry Drees
Journal: International Clinical Trials, ICT
Date: May 2010