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Services
Regulatory
Clinical Documentation
Briefing Book
Clinical Development Plan
Clinical Study Protocol (CSP)
Clinical Study Report (CSR)
Lay Summaries
Common Technical Document (CTD)
Informed Consent Form (ICF)
Investigator’s Brochure (IB)
Investigational Medicinal Product Dossier (IMPD)
Investigational New Drug (IND)
Paediatric Investigation Plan (PIP)
Pediatric Study Plan (PSP)
Responses to Authority Questions
Clinical Evaluation Report (CER)
Other Documents
Postmarketing
Postmarketing Studies
Pharmacovigilance
PV & Product Safety
120 Day Safety Update (4 Month Safety Update)
Development Safety Update Report (DSUR)
Periodic Adverse Drug Experience Report (PADER)
Periodic Safety Update Report (PSUR)
Periodic Benefit Risk Evaluation Report (PBRER)
Risk Evaluation and Mitigation Strategies (REMS)
Risk Management Plan (RMP)
Communications
Scientific Communications
Abstracts and Manuscripts
Posters and Slide Sets
Training
Training Overview
Training Portfolio
Foundation Skills Training Programme
Preparing Specific Clinical Documents
Strategic Communication Skills
Why Trilogy?
What is Medical Writing?
Why use Trilogy?
Outsourcing
Expertise
Therapeutic Areas
Development Areas
Trilogy Benefits
How We Work
Trilogy Style Guide & Tools
Document Review Process
Customer References
Trilogy Brand Brochure
AI
NEXT Medical Writing Automation
About Us
Our Story
Trilogy Management Board
FAQ
Resources
TriloTalk | Podcast
Publications
Medical Writing Special Editions
Special Edition: Ctrl+Alt+AI: Rebooting the Future of Medical Writing
Special Edition: Communicating With Patients: Why it Matters and How to Do it Better
Special Edition: Clinical Study Protocols: The Pillars of Clinical Development
Special Edition: Medical Writing – A Bold New Path: The Future Awaits Us
Special Edition: Medical Writing: The Backbone of Clinical Development
Think Tanks
Glossary of Clinical Research Terms
News: Regulations & Standards
Careers
Come join us
Life at Trilogy
Contact
Type: Publications
Finding the Answers
Responding to authority questions - how medical writers can streamline the relay race.
>> Read More
Author:
Julia Forjanic Klapproth
Journal:
European Pharmaceutical Contractor, EPC
Date:
March 2012
Download as PDF
Strategic Medical Writing: why settle for less?
Good medical writers serve as communication specialists and advisors on getting your message across.
>> Read More
Author:
Julia Forjanic Klapproth
Journal:
BrAPP, British Association of Pharmaceutical Physicians
Date:
Vol.22, No.6, May 2012
Download as PDF
Medicines for Children
Preparing the Paediatric Investigation Plan (PIP) application.
>> Read More
Author:
Douglas Fiebig
Journal:
International Clinical Trails, ICT
Date:
May 2011
Download as PDF
Cutting Back: solutions to reduce the time and costs of clinical development
Outsourcing and Functional Service Provision (FSP) of medical writing
>> Read More
Author:
Julia Forjanic Klapproth
Journal:
International Clinical Trials, ICT
Date:
November 2009
Download as PDF
Regulatory Questions and Answers: The Investigator's Brochure
Advice on the appropriate format for the Investigator's Brochure.
>> Read More
Author:
Douglas Fiebig
Journal:
The Write Stuff, The journal of EMWA
Date:
Vol.9, No.3, 2000
Download as PDF
Medical Writing: Outsourcing Guide
What and when to outsource, how to find a medical writing partner.
>> Read More
Author:
Julia Forjanic Klapproth
Journal:
European Pharmaceutical Contractor, EPC
Date:
December 2010
Download as PDF
The New Documentation Paradigm – the evolution of medical writing into a strategic function
The evolution of medical writing into a strategic function.
>> Read More
Author:
Julia Forjanic Klapproth and Barry Drees
Journal:
International Clinical Trials, ICT
Date:
May 2010
Download as PDF
