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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 Writing | Pediatrics | Pharmacovigilance | Postmarketing | Responses to Authority Questions | Risk Management Plan (RMP) | Value of Medical Writing | Diversity, Equity and Inclusion (DEI)
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
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
Communicating With Patients: Why It Matters and How to Do It Better
Welcome to the Medical Writing Supplement of International Clinical Trials. We are delighted to present this edition, where we explore the landscape of communicating with
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
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
AI & Automation
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
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
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
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 &
Episode 16: AI for Medical Writing – Turkeys Voting for Christmas?
In this special episode, Lisa and Barry, Senior Partners at Trilogy, along with Jamie Norman, Chief Product Officer at TriloDocs joined Network Pharma at its
Episode 23: Speaking of Buzzwords in Medical Writing, What About AI? – Part II
Welcome back to TriloTalk! As promised, we are continuing the conversation about buzzwords in medical writing. In this episode, our guests Lisa and Art explore
Briefing Book
Episode 15: How to Streamline Regulatory Authority Meetings: Spotlight on Briefing Books
Welcome to TriloTalk episode 15, where we will dive into the critical document that plays a pivotal role in pharmaceutical development: The Briefing Documents (or briefing books/packs). Join Barry and Maria as they explore the key elements of well-crafted Briefing
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?
Common Technical Document (CTD)
Document Review & QC
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. These documents would be drafted in a secure environment. Version
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
Getting the most out of quality control specialists: Practical guidance for medical writers
Quality control (QC) is a process that usually occurs when a document is in a near-final or final state. It involves the checking of documents by QC specialists against source data (e.g., comparing data in tables and checking that analytical
Good Review Process – The New Panacea
Over the last 25 years, the way we write regulatory documents has evolved – from lean writing to technology that aids in populating the reports we write, things have gotten more streamlined. Which is a good thing, considering the goal
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)
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
European Medical Writers Association (EMWA)
The history of The Write Stuff: 10 years of bringing European medical writers together
Barry Drees reflects on 10 years as editor of the journal of European Medical Writers Association.
Medical Devices
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
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
The Clinical Evaluation Report: Bringing it Together
In light of recent regulations, it is important to discuss the general aspects and strategies for writing and compiling a CER. In Europe, a clinical evaluation report (CER) is now a key element in assessing the fitness of a medical
The Clinical Evaluation Report: Document Writing and Compilation
Trilogy offers high-end medical writing that goes beyond just making sure a document is structured properly: it involves content-driven sanity checks, a sense of ownership of the documents and offering strategic support on all areas of document production – from
Medical Writing Apprenticeships
Achieving a Work-Life Balance as Medical Writers
In any industry, there is considerable evidence of the value and improved productivity for those who maintain a healthy work-life balance, and we should not forget that a near total neglect of life is not sustainable. “We don’t live to
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
How to Build a Medical Writer: Medical Writing Apprenticeships – New Training for a New Breed
Everyone involved in preparing regulatory documentation in the pharmaceutical industry is always on a desperate look out for excellent medical writers with years of experience writing the documents they need. But those mythical beasts are few and far between. One
Outsourcing Medical Writing
Cutting Back: solutions to reduce the time and costs of clinical development
Outsourcing and Functional Service Provision (FSP) of medical writing
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
Medical Writing: Outsourcing Guide
What and when to outsource, how to find a medical writing partner.
Reverse auctions: the perfect folly for sourcing clinical research services
Are reverse auctions (e-auctions) between suppliers of services as good as sometimes claimed?
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
Under the Hammer
Inappropriate use of reverse auctions puts suppliers at an unfair loss and disadvantages buyers.
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
Lay Summaries
Communicating with Patients – Common Sense or a “Black Art”?
Good patient information maximises the benefits and intended use of a medicine.
Communicating with Patients. Who and How?
Despite the fact that patient-friendly versions of many regulatory documents are now mandated by the regulations, the most frequently encountered reaction to communicating patient information is apathy.
Communicating With Patients: Why It Matters and How to Do It Better
Welcome to the Medical Writing Supplement of International Clinical Trials. We are delighted to present this edition, where we explore the landscape of communicating with patients and the general public. From grasping the societal significance of effective interaction to offering
Do We Need to Involve Patients in Clinical Study Report Lay Summaries?
Translating complex clinical regulatory documents into versions that are understandable to patients and the general public was never going to be an easy task, but it is a very necessary, important, and now legally mandated one. This article argues that
Episode 12: PIF and PIF Tick. What are these and why are they important?
In this episode, Lisa Chamberlain James, Senior Partner at Trilogy Writing & Consulting talks to Dan Wills, Quality Mark Manager at Patient Information Forum (PIF) about the PIF TICK accreditation and its importance – specifically, what it means for organizations to have
Episode 19: Elevating the voice of patients: the role of medical writers in making a difference
In this episode, Lisa Chamberlain James, Senior Partner at Trilogy Writing & Consulting, and Magnolia Correa, Marketing Communications Manager at Trilogy Writing & Consulting, delve into their shared passion for patient communication. They explore this topic from their different perspectives
Episode 26: The Future of Lay Summaries – Leveraging AI for Patient-Friendly Language
Welcome back to TriloTalk! In this episode, Lisa Chamberlain James from Trilogy and Vladimir Penkrat and Ritesh Dogra from Indegene dive into the role and future of lay summaries. AI technology, new EUCTR requirements, graphic creation, and much more will
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
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
Lay Summaries and Writing for Patients: Where Are We Now and Where Are We Going?
We examine the trend for increasing and more transparent patient information and ask how close we have come in the last few years to producing useful and meaningful information for patients. We also outline the challenges faced by medical writers
Mind the Gap
Why the move for more and better patient information is gathering momentum.
Plain Language Summaries of Publications – what has COVID-19 taught us?
The COVID-19 pandemic has significantly impacted the whole world and the public has had to struggle with understanding scientific data on a daily basis. The impact of scientific misunderstanding became painfully apparent with the decline in vaccine uptake and so
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
The Lay Protocol Synopsis: Requirements and Feasibility
In 2014, the EU introduced a new regulation: EU CTR 536/2014.1 This regulation replaced the previous Clinical Trials Directive 2001/20/EC,2 and became mandatory with the opening of the Clinical Trials Information System (CTIS) on January 31, 2022. The new regulation
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
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
TriloTake on Lay Summaries
Listen to Lisa Chamberlain James, Senior Partner at Trilogy, talk about her take on Lay Summaries – what are the opportunities and what are the challenges?
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
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.
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.
Lean Medical Writing (LMW)
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
Keeping it lean: hitting the Goldilocks level of detail in medical writing
It is crucial to apply lean medical writing principles when drafting regulatory documents, to ensure they are as informative as possible while being concise and readable – how can this be achieved? The principles of lean medical writing continue to
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
Pharmacovigilance and Product Safety
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:
Regulatory submissions of non-interventional post-authorisation safety studies: Challenges for data interpretation and comparisons with clinical data
The post-authorisation safety study (PASS) is a pharmacovigilance activity often required as a post-marketing commitment to establish a safety profile or address specific safety concerns. An imposed PASS must be submitted in common technical document format. Comparability of observational studies
Strategic Medical Writing in the Post-Authorisation Phase
The latest legislation for the most common post-authorisation documents (RMP, PSUR, safety studies).
The challenges of producing periodic benefit–risk evaluation reports
This article discusses the challenges of producing a periodic benefit–risk evaluation report (PBRER) from a writing perspective. It explains that by taking into consideration the most common pitfalls encountered by regulatory assessors, companies can improve the quality of their PBRERs
The Pharmacovigilance Medical Writer: Medical Writer, Project Manager, Regulatory Expert
Pharmacovigilance is a critical element of drug development and marketing. The evaluation and monitoring of patient safety and a drug’s benefit/risk is a highly regulated global task, which is required continuously throughout a drug’s lifecycle. The results of such analyses
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 set of unique opportunities and challenges. The screening and reporting
Postmarketing Clinical Research
Planting the Seed: Post-Marketing Research
The importance of good planning and communication for the success of postmarketing research.
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.
Responses to Authority Questions
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
Finding the Answers
Responding to authority questions – how medical writers can streamline the relay race.
Responses to Regulatory Authorities: Measure Twice – Cut Once
March 15, 2018 | North Carolina, US Trilogy hosted a discussion on how to make the process of writing and coordinating these responses as efficient as possible, together with our speakers:
The FDA, EMA, and PMDA Questions: How to Respond During Review of CTD Submission Dossiers
While the ICH’s Common Technical Document (CTD) is an internationally agreed format for preparing application dossiers needed for obtaining approval to market a drug, the ensuing review process is specific to the country or region in question. Irrespective of the
The Clinical Study Protocol (CSP)
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 Trials (ICT). In this edition, we focus on the importance
Episode 14: The Importance of Getting Clinical Protocols Right
In this episode, Julia and Jonathan cover how making people aware of the many new and updated regulations (such as the ICH E8(R1) and the draft ICH M11 guideline) will help ensure teams are following these, looking for ways to
Episode 18: Clinical Study Protocol Development from a Writer’s Perspective
Join Julia and Jonathan for the 2nd part of a discussion dedicated to the development of Clinical Study Protocols as they delve into the intricacies of writing these crucial documents. In this discussion, they explore the level of involvement a
How well-written clinical study protocols get drugs to patients faster
In the world of drug development and approval, time is of the essence. But beginning the process with a poorly written protocol will only impede teams before a study has even begun. Julia Forjanic Klapproth, co-founder of Trilogy Writing &
Reaping the Benefits from Improved Clinical Study Protocols
Clinical study protocols are important cornerstones on the journey of collecting the clinical data needed to elucidate the benefit-risk profile of medical treatments/devices. Not only do they lay down the plan for the study at hand, they serve as a
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
The reproducibility crisis in preclinical research – lessons to learn from clinical research
In recent years, the robustness and reproducibility of preclinical data have been a topic for discussion. Quality standards and good practices are often not well defined for different in vitro methods and in vivo models, and not harmonised amongst preclinical
Words of Wisdom: writing Protocols
The ABCs of writing effective Clinical Study Protocols
The Importance of Good Communication and Documentation
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
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
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
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
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.
Good Review Process – The New Panacea
Over the last 25 years, the way we write regulatory documents has evolved – from lean writing to technology that aids in populating the reports we write, things have gotten more streamlined. Which is a good thing, considering the goal
I did it so you don’t have to: Lessons learned as a young writer struggling with a regulatory document
Medical writing is not easy, especially for new writers still learning the ropes. We are exposed to new documents, therapeutic areas, procedures, and challenges regularly and the fast-paced and ever-changing environment can be stressful. Nowadays, there are resources and initiatives
In regulatory submission writing, a project facilitator is the yin to a medical writer’s yang
Regulatory submission writing is an enormous and costly endeavour that begins during preclinical development and continues even after the product has been approved. Marketing applications encompass a series of documents that, combined, may exceed several thousand pages. These include clinical
Medical Writing in the Old World
Although there has been what amounts to medical writing here for a long time, it is a relatively new concept as a specialized profession.
Remote meetings made easy: Good practices to keep in mind
Abstract One core medical writing skill is effectively communicating with the teams that will help us author our documents. With remote working playing an increasingly important role in our workforce, medical writers must adapt to this new reality. This article
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
What you Need and When – The Key Documents in the Drug Lifecycle
Clinical development is a complex and expensive undertaking, involving many years of research that culminate with clinical trials, the objectives and results of which all have to be documented. This article provides a pathfinder to which documents need to be
The Investigator’s Brochure (IB)
Regulatory Questions and Answers: The Investigator’s Brochure
Advice on the appropriate format for the Investigator’s Brochure.
The Investigator’s Brochure – A multidisciplinary document
The Investigator’s Brochure (IB) B is primarily written to enable investigators to assess risks and benefits.
The Paediatric Investigation Plan (PIP) and the Pediatric Study Plan (PSP)
Writing Pediatric Study Plans (PSPs) – The Impact of the Revised 2016 FDA Draft Guidance
An initial Pediatric Study Plan (iPSP) is an outline of the paediatric study or studies that the drug development sponsor plans to conduct in the US to confirm the suitability of drug usage in the paediatric population. Initial Pediatric Study
The Risk Management Plan (RMP)
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.
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:
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
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.
Value of Medical Writing
Episode 20: Q&A With Trilotalk: Focus on General Medical Writing Principles
In this episode, Julia and Lisa take a deep dive into General Medical Writing Principles. Join them as they navigate through a diverse range of topics that are crucial in the everyday practice of crafting clear and concise regulatory documents.
Episode 28: Exploring the Past, Present and Future of Orphan Drugs
Long time friends and industry colleagues, Lisa Chamberlain James with Trilogy and Cheryl Roberts with BioMarin Pharmaceutical sit down to discuss orphan drugs. They go over clinical trial hurdles, key incentives for health authorities, the medical writing process and start
Episode 3: The Value of Medical Writing
“Pay me now or pay me later”. TriloTalk episode 3 features Julia and Gretchen Griffin as they talk and discuss the value of medical writing and what a good medical writer brings to the table.
How well-written clinical study protocols get drugs to patients faster
In the world of drug development and approval, time is of the essence. But beginning the process with a poorly written protocol will only impede teams before a study has even begun. Julia Forjanic Klapproth, co-founder of Trilogy Writing &
Medical Writing in the Old World
Although there has been what amounts to medical writing here for a long time, it is a relatively new concept as a specialized profession.
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
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
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
Writing for 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”.