Publications

Filter by Publication Topic: AI & Automation | Biosimilars | Briefing Book | Clinical Development Plan (CDP)Clinical Study Protocol (CSP) | Common Technical Documents (CTD) | Document Review & QC | EMWA | Good Communication and Documentation | Investigator’s Brochure (IB) | Lay Summaries | Lean Medical Writing (LMW)Medical Devices | Medical Writing Apprenticeships | Outsourcing Medical WritingPediatrics | Pharmacovigilance | Postmarketing | Responses to Authority Questions | Risk Management Plan (RMP) | Value of Medical Writing

Special Editions: A Bold New Path: The Future Awaits | The Backbone of Clinical Development | Clinical Study Protocols: The Pillars of Clinical Development

Special Editions

Clinical Study Protocols
Clinical Study Protocols: The Pillars of Clinical Development
Welcome to the 2023 Medical Writing Supplement developed as a collaboration between Samedant Ltd and Trilogy Writing & Consulting and published as part of the Winter edition of International Clinical...
Journal: Medical Writing Supplement of International Clinical Trials, ICT
Date: February 2023
Medical-Writing-Special-Edition-2-Front-Cover
Medical Writing - A Bold New Path: The Future Awaits Us
The second edition of Trilogy’s special edition magazine, Medical Writing – A Bold New Path: The Future Awaits Us, was published at the beginning of 2020. Once again, Trilogy Writing...
Journal: Special Edition of International Clinical Trials, ICT
Date: February 2020
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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

AI & Automation

Screenshot 2023-10-09 112949
AI for Medical Writers – Friend or Foe?
Artificial Intelligence (AI) is beginning to affect almost every industry, and medical writing is no different. But how does this relate to our industry? How will AI affect medical writers? What’s already available and what is in the pipeline? Should medical writers be happy and embrace the technology, or should we resist as much as we can, assuming that we will all be replaced by machines? This article discusses the current state of the art of AI in medical writing and asks the question: AI for medical writers – friend or foe?
Author: Lisa Chamberlain James and Jamie Norman
Journal: Journal for Clinical Studies
Date: September 2023
Cover-Picture-OCT-handbook-2021
Artificial intelligence for medical writing, part two: transparency, flexibility and control
In an earlier article about artificial intelligence (AI) for medical writing1, I stressed that AI tools would assist, accelerate and augment the process of clinical documentation. I also argued that the key to the third aspect, augmentation, was the use and future acceptance of standard texts.
Author: Barry Drees
Journal: Outsourcing in Clinical Trials Handbook 2022
Date: December 2021
OCT-Handbook-2021
AI for Medical Writing: Assistance, Acceleration and Augmentation
The promise of AI for the field of medical writing has been apparent for some time and a number of teams have created tools of varying effectiveness and scope. Dr....
Author: Barry Drees
Journal: Outsourcing in Clinical Trials Handbook 2021
Date: October 2020
Clinical-Trials-Insight-Cover-Summer-2020
Assistance, Acceleration and Augmentation
AI is set to play a significant role in regulatory and medical writing in the very near future. Dr Barry Drees of Trilogy Writing & Consulting, using his more than...
Author: Barry Drees
Journal: Clinical Trials Insight
Date: Summer 2020
Medical-Writing-Special-Edition-2-Front-Cover
Truth be Told: Where AI and Automation Can Really Take Us
AI and automation are both exciting and daunting prospects in the future of medical writing, but the advantages of these tools should be scrutinised, as well as what they mean...
Author: Julia Forjanic Klapproth
Journal: Medical Writing Special Edition No. 2
Date: February 2020

Biosimilars

Generics and Biosimilars
Biosimilar Development – An Overview
Biosimilars are biological drugs that are similar to, and cheaper than other biological drugs (called “reference originator biologics”) that are already in use. They share an identical amino-acid sequence but, given the inherent variability of biological molecules, not full “sameness”.
Author: Diana Radovan
Journal: Medical Writing, the journal of EMWA
Date: Summer 2019

Briefing Book

ICT-May-2022
How to Streamline Regulatory Authority Meetings
Streamlining meetings with regulatory authorities is a continually evolving process. But what role do briefing documents play, and what is the best way to produce these effectively?
Author: Maria Mascarenhas and Barry Drees
Journal: International Clinical Trials
Date: May 2022

Clinical Development Plan (CDP)

EPC Journal
The Clinical Development Plan – The Importance of Getting it Right
Given the extreme complexity and difficulty of developing new pharmaceutical products, one would think that the planning for such an endeavour would be taken very seriously. Yet, somewhat surprisingly, it frequently is not.
Author: Barry Drees and Julia Forjanic Klapproth
Journal: European Pharmaceutical Contractor, EPC
Date: November 2020

Clinical Study Protocol (CSP)

Common Technical Document (CTD)

Document Review and QC

European Medical Writers Association (EMWA)

Good Communication and Documentation

Investigator’s Brochure (IB)

Lay Summaries

Lean Medical Writing (LMW)

Medical Devices

Medical Writing Apprenticeships

Outsourcing Medical Writing

Paediatric Investigation Plan (PIP) and the Pediatric Study Plan (PSP)

Pharmacovigilance and Product Safety

Postmarketing Clinical Research

Regulatory Submissions and Authority Questions

Risk Management Plan (RMP)

Value of Medical Writing