ALL Resources

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: Communicating With Patients: Why it Matters and How to Do It Better | A Bold New Path: The Future Awaits | The Backbone of Clinical Development | Clinical Study Protocols: The Pillars of Clinical Development

Special Edition

AI & Automation

Briefing Book

Common Technical Document (CTD)

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Episode 11: Taming the Complexity of Preparing CTD Submission Dossiers
Process optimization, effective management, and organisation strategies are all essential components when preparing CTD submission dossiers for drug approval.
Date: July 2022
Responses to Regulatory Authorities
Episode 8: Responses to Regulatory Authorities
In this episode, Julia and Douglas, Senior Partners at Trilogy Writing & Consulting, discuss how preparing written responses to questions received from regulatory agencies during the review of application dossiers...
Date: April 2022
A Primer for Writing Oncology Dossiers
Episode 7: A Primer for Writing Oncology Dossiers
In this episode, Julia Forjanic Klapproth, Senior Partner, and Maurice Löwens, Medical Writing Manager at Trilogy Writing & Consulting, discuss how experienced medical writers can streamline the planning and writing...
Date: March 2022
OCT-2022-Cover-Page
How to streamline a complex process: why experienced medical writers will add value to oncology dossiers
Oncology is one of the most common areas of drug development in the pharmaceutical industry. In 2020, many of the new drugs approved by the FDA were cancer treatments. Existing...
Author: Julia Forjanic Klapproth and Maurice Löwens
Journal: Clinical Operations in Oncology Trials Handbook 2022
Date: December 2021
Medical-Writing-Special-Edition-2-Front-Cover
Taming the Complexity of Preparing CTD Submission Dossiers
Process optimisation and effective management and organisation strategies are essential components when preparing CTD submission dossiers for drug approval. “Be prepared.” In his book, Scouting for Boys, Robert Baden-Powell introduced...
Author: Douglas Fiebig, Johan Telen
Journal: Medical Writing Special Edition No. 2
Date: February 2020
Medical-Writing-Special-Edition-2-Front-Cover
Implications of Policy 0070 for the Writing of Clinical Dossiers
EMA Policy 0070 requires the publishing of all clinical reports submitted as part of MAAs, so it is important to highlight what new challenges this may bring for the writing...
Author: Julia Forjanic Klapproth, Jo Anne-Marie Blyskal
Journal: Medical Writing Special Edition No. 2
Date: February 2020
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The Challenge of CTD Submissions and Responding to Questions from the Authorities
The Common Technical Document is an international standard for the summary documents needed to obtain regulatory approval of medicinal products. These summary documents involve presenting key information drawn from a...
Author: Douglas Fiebig
Journal: Special Edition of International Clinical Trials, ICT
Date: February 2017
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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

Document Review & QC

The Power of Good Review Practice
Podcasts

Episode 4: The Power of Good Review Practice

In this episode, Julia and Barry, Senior Partners at Trilogy Writing & Consulting, call for a “revolution and complete overhaul in the way documents are reviewed”. They explain how a focused review process leads to a transformational change in how

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EMWA-Journal-27-4
Publications

Help Reviewers Tell You What They Want

Review is an integral part of the medical writing process and relies on clear communication between the medical writer and the reviewer(s). This is a two-way street. Review can be a frustrating process for both the writer and the reviewer(s)

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Medical-Writing-Special-Edition-2-Front-Cover
Publications

Help Reviewers Tell You What They Want

Reviewers of regulatory documents need to ensure that their comments are specific, actionable, and relevant, so that no critical time is spent unnecessarily throughout the document development process. Review is an integral part of the medical writing process and relies

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European Medical Writers Association (EMWA)

Medical Devices

medical-device-developments-journal
Publications

Getting the Writing Right

Gerry McGregor, a principal medical writer at Trilogy Writing & Consulting, explains how experienced medical writers can help medical device manufacturers to meet the new regulatory demands of producing clinical evaluation reports. In Europe, a clinical evaluation report (CER) is

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MedDevDev
Publications

Strategic medical writing for device submissions

Julia Forjanic Klapproth of Trilogy Writing & Consulting GmbH elucidates how it’s time to start using strategic medical writing in the world of device submissions. Until recently, the documents needed for device evaluations were not well defined and were generally

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Medical Writing Apprenticeships

Apprenticing Medical Writers
Podcasts

Episode 6: Apprenticing Medical Writers

In this month’s episode, Julia Forjanic Klapproth, Senior Partner at Trilogy Writing & Consulting, and Joan Affleck, Head of the Medical Writing Department at Merck, talk about the medical writing training programs at the companies they represent and explore how

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Outsourcing Medical Writing

Publications

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 is no different, measuring the service provided for medical writing

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Publications

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 of providers. The challenge that arises in such a rapidly

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Publications

You Get What You Give

Julia Forjanic Klapproth, co-founder of Trilogy Writing & Consulting, explains how to prepare good requests for information and proposals in the field of medical writing. If you have ever been involved in the process of selecting a company to provide

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Lay Summaries

Lay Summaries
Podcasts

Episode 5: Lay Summaries

Writing for a non-specialist audience represents challenges beyond writing in a simpler language. Writing a fit-for-purpose document for the general public involves lay language, lay presentation, and lay science. Join Dr. Lisa Chamberlain James and Dr. Barry Drees as they

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CTI2019.2
Publications

Lay Summaries and Writing for Patients

The most recent changes to regulatory legislation in terms of information for patients – the introduction of the lay summary of the risk management plan (RMP) and the lay summary of clinical trial results (CTRs) – have caused great discussion

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Risk-management-plans-and-summary-for-the-lay-reader-think-tank-Frankfurt-July-2016
Think Tanks

Risk Management Plans and Summary for the Lay Reader

July 12, 2016 | Frankfurt, Germany Trilogy hosted a discussion on every-day challenges involved in meeting the guideline on good pharmacovigilance practices (GVP), the challenge of writing and managing Risk Management Plans (RMPs), including the newly legislated Part VI.2 of

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Journal for Clinical Studies FC
Publications

The Lay Summary – Remember the Reader

As part of its Clinical Trial Transparency initiative, the EMA mandated a requirement for clinical trial sponsors to prepare a summary of the results of every clinical trial written in language understandable to lay persons (patients and others not in

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OCT-Handbook-Cover-2020
Publications

The Lay Summary – Remember the Reader

In 2014, as part of its Clinical Trial Transparency initiative, the EMA mandated a requirement (CTR EU No 536/2014) for clinical trial sponsors to prepare a summary of the results of every clinical trial written in language understandable to lay

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Medical-Writing-Special-Edition-2-Front-Cover
Publications

Writing for Patients: When and How

In a drive for more patient-centric healthcare practices, medical writers are increasingly required to present medical and health information in an easy-to-understand, ‘plain language’ format. The move towards patient engagement and patient involvement in healthcare decisions (‘shared care’) has triggered

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Think Tanks

Writing Lay Summaries

November 05, 2020 | Virtual Trilogy hosted a discussion on writing Lay Summaries and their experience on how to overcome the unique challenges found when writing these types of documents.

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Think Tanks

Writing Lay Summaries

January 22, 2020 | London, UK Trilogy hosted a discussion on writing Lay Summaries and their experience on how to overcome the unique challenges found when writing these types of documents.

Read More »

Lean Medical Writing (LMW)

Lead Medical Writing
Podcasts

Episode 1: Lean Medical Writing

In this episode, Julia and Barry talk about the importance of lean medical writing to communicate the key messages efficiently. The goal is story, not storage. They discuss how less is more and the importance of giving answers to the

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Clinical-Trials-Insight-July-2021
Publications

Lean Medical Writing: Story not Storage

The most difficult task an author can face is clearly summarising a complex and data-filled clinical regulatory document and explaining the data. Barry Drees, co-founder and senior partner of Trilogy Writing & Consulting, discusses the recent concept of ‘lean medical

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Pharmacovigilance and Product Safety

Good-Pharmacovigilance-Practices-Think-Tank-London-June-2015
Think Tanks

Good Pharmacovigilance Practices

June 18, 2015 | London, UK Trilogy hosted a discussion on the challenges posed by the guideline on good pharmacovigilance practices (GVP) with a special focus on Risk Management Plans (RMPs), together with our speakers:

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Postmarketing Clinical Research

Responses to Authority Questions

Responses to Regulatory Authorities
Podcasts

Episode 8: Responses to Regulatory Authorities

In this episode, Julia and Douglas, Senior Partners at Trilogy Writing & Consulting, discuss how preparing written responses to questions received from regulatory agencies during the review of application dossiers can be decisive to the outcome of the review, and

Read More »

The Clinical Study Protocol (CSP)

Medical-Writing-Cover-722x1024
Publications

Streamlining Clinical Study Protocols and Reports

Recent pharma initiatives have been established to help ensure that clinical study protocols and reports are always presented in a similar way, making for easier assimilation and assessment. This article discusses these initiatives, and outlines their key recommendations. As we

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The Importance of Good Communication and Documentation

WorldPharma-2016 Vol 2
Publications

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 Writing & Consulting co-founder Julia Forjanic Klapproth discuss the ways

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The Importance of Style Guides
Podcasts

Episode 10: The Importance of Style Guides

Restrictive or time saving? In this episode, Barry, Senior Partner at Trilogy Writing & Consulting, reflects on the importance of style guides and how these can serve as a compass to accompany medical writers when deciding on the grammatical or

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Lead Medical Writing
Podcasts

Episode 1: Lean Medical Writing

In this episode, Julia and Barry talk about the importance of lean medical writing to communicate the key messages efficiently. The goal is story, not storage. They discuss how less is more and the importance of giving answers to the

Read More »
The Power of Good Review Practice
Podcasts

Episode 4: The Power of Good Review Practice

In this episode, Julia and Barry, Senior Partners at Trilogy Writing & Consulting, call for a “revolution and complete overhaul in the way documents are reviewed”. They explain how a focused review process leads to a transformational change in how

Read More »
The Ethics of Medical Writing
Podcasts

Episode 9: The Ethics of Medical Writing

Rapid dissemination of scientific information, lower standards in review processes, unvetted information. In this episode, Barry, Senior Partner at Trilogy Writing & Consulting, and Art, Principal at MedSciCom, explore the never-ending ethical situations that are deep-rooted in the profession of medical writing.

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AMWA Journal Winter Cover 2022
Publications

The Future of Medical Writing: A Panel of One

Of all the points in the evolution of the medical writing profession, I believe we are at the pinnacle of what promises to be the most exciting and biggest paradigm shift in medical writers’ roles and responsibilities. With an accompanying

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The Investigator’s Brochure (IB)

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

The Risk Management Plan (RMP)

PBRERs-and-RMPs-think-tank-london-November-2017
Think Tanks

PBRERs and RMPs

November 14, 2017 | London, UK Trilogy hosted a discussion on the main challenges on PBRERs and RMPs and reviewer insights, together with our speakers:

Read More »
Risk-management-plans-and-summary-for-the-lay-reader-think-tank-Frankfurt-July-2016
Think Tanks

Risk Management Plans and Summary for the Lay Reader

July 12, 2016 | Frankfurt, Germany Trilogy hosted a discussion on every-day challenges involved in meeting the guideline on good pharmacovigilance practices (GVP), the challenge of writing and managing Risk Management Plans (RMPs), including the newly legislated Part VI.2 of

Read More »

Value of Medical Writing

Cover-Pharma-Tech-Outlook
Publications

Quality-Driven Medical Writing

For years, the clinical drug development industry has been waging war against the surging drug development costs and tediously long processes. More efficient decision making during drug development would be a crucial differentiator that the industry needs to win this

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ICT Front Cover
Publications

Strategic Benefits

Julia Forjanic Klapproth of Trilogy Writing and Consulting elucidates how strategic medical writingcan help communicate key messages across development programmes and make sure teamsstay focused on a common goal. I am going to pose a rhetorical question. How early should

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ICT-Magazine-The-Future-Awaits-Us-Article-May-2020
Publications

The Future Awaits Us

Off the back of the release of Trilogy Writing & Consulting’s second special edition magazine, EPC sits down with Barry Drees to expand on medical writing trends in the industry. EPC: In Medical Writing –  A  Bold New Path: The

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Writing for Biosimilars

Generics and Biosimilars
Publications

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”.

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