Guidance

The Investigator’s Brochure: Multifaceted and Multidisciplinary

Metathesiophobia: from Preclinical to Clinical Development

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The Investigator's Brochure Has Become a Regulated Safety Instrument. Is Your Organisation Ready?

ICH E6 R3 has reset expectations for the Investigator's Brochure. What sponsors and medical writers need to know about safety reporting in...

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Awesome abstracts

You may think that 'writing the abstract' simply  involves summarising

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Toot your horn...

People working in the sciences aren’t generally perceived as being outgoing.

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Baffling bibliometics

The prestige of publication has been based on traditional citation metrics

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Clinical study reports under the microscope

Metathesiophobia: from Preclinical to Clinical Development

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From Hand-Written Bibliographies to AI-Hallucinated Citations

Fabricated citations have grown 12-fold since 2023. A look at the Lancet audit and what the AI hallucination crisis means for scientific...

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Is Disruptive Science in Decline?

Scientific output has never been higher, yet truly disruptive discoveries appear to be declining. A look at why breakthrough science is...

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Repurposing drugs for COVID-19 complications

A fascinating science news story hit the headlines in the last 24 hours, that a common over-the-counter ingredient in many cough syrups may...

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Challenge trials: What you need to know

The world's first human COVID challenge trial has been given the green light

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Clinical Trials Are Getting More Complex. That Is Why More of Them Are Failing.

Clinical trial complexity has risen over 10% in a decade, driving longer timelines and higher failure rates. A look at what sponsors can do...

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Content-Driven Irritation:AI Slop and Shallow LinkedIn Content

How the digital age has transformed the way we communicate, share information, and consume content.

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From Bench to Byline: What It Really Means to Become a Medical Writer

Many medical writers start as scientists. A candid look at what the transition from bench to medical writing really involves and what it...

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Get Visible or Vanish: 10 Rules for Promoting Your Research

Publishing is just the first step. Ten practical activities to increase the discoverability and impact of your research in a crowded...

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The question that never goes away: How Long Does Medical Writing Actually Take?

How long does medical writing actually take? An honest look at what drives timelines, where time is lost and why speed comes with...

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Meaningful Conversations: How and Why They Matter

How meaningful conversations build trust, improve wellbeing, and why authenticity matters more than ever in a digital-first world.

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Understanding your fears

In the past, Halloween has meant the end of the crop and the start of the dark, cold winter.

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A Shortening Shelf Life for Medical Guidance

Half of clinical guidelines are outdated within 6 years. How should medicine respond to the shrinking shelf life of medical knowledge in an...

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How Good a Writer Are You Really? 6 Techniques for Honest Self-Evaluation

Self-doubt is common among medical writers. Practical techniques for evaluating your own writing objectively and developing your craft with...

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You will be judged

Most writers fear judgement of their work. Practical techniques for reviewing your own writing objectively and building confidence as a...

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Initialisms, Acronyms, and Abbreviations: A Plea for Sanity (and Clarity)

60 abbreviations in one document is not writing, it is archaeology. A practical guide to using abbreviations correctly, safely and sparingly...

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The Pen vs. The Prompt: You will be judged II

AI can make your writing perfect but at what cost? A look at cognitive debt, authenticity and why the human fingerprint still matters more...

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Artificial intelligence: Pandora's box?

ChatGPT is reshaping medical writing and scientific communication. A critical look at the benefits, limitations and risks of AI in research...

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Ten tips for promoting your research

Discover ten evidence-based strategies to promote scientific research, improve dissemination, increase impact, and strengthen long-term...

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How is Innovation Shaping the Future of Health Communications?

Innovation in health communications is not about new tools. A look at AI risks, intent driven strategies and what meaningful progress...

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May the Fourth: Humour, Popular Culture, and Science Engagement

A pun that travels the galaxy. How Star Wars Day uses humour, awe and cultural storytelling to make science accessible and why that matters...

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What Prolonged Sitting Is Really Doing to Medical Writers Working from Home

Homeworking has made sedentary behaviour worse for medical writers. The health risks of prolonged sitting and what to do about it.

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If, and Only If: When Does a Medical Writer Qualify for the Next Level Up?

Promotion in medical writing is rarely about time served. A candid look at what actually drives career progression and why growth matters...

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The Production and Impact of Graphical Abstracts in Scientific Communication

Graphical abstracts boost engagement but do they improve scholarly impact? A critical look at how visual abstracts work and where they fall...

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Inside our Insider’s Insights

Metathesiophobia: from Preclinical to Clinical Development

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Twenty-Eight Years On: Sustaining Scientific Enterprise, Motivation, and Meaning in a Changing Workforce

What keeps a founder engaged after 28 years? Niche CEO Tim Hardman reflects on motivation, resilience and why long-term leadership can...

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Walking Deadlines: An Undead Perspective on Managing Zombie Manuscripts

A zombie manuscript has all the vital signs but no soul. How disengaged teams kill scientific papers and what medical writers can do about...

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Efficient Document Editing: A three-phase workflow

You can waste a considerable amount of time when reviewing and editing

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Under‑Reporting of Clinical Studies

We have some strange terms in the pharma industry

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Editing tip: Size is important

Writing that is short is vigorous.

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Fright here, fright now

Chronic overwhelm is the real workplace horror. A look at the cognitive science of workplace fear, multitasking overload and why delegation...

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Aiming at Supererogation

From Tuskegee to the Belmont Report, how did modern research ethics come to be? A reflection on 40 years of principles that still govern...

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Which Conference Monster Are You and How Do You Escape It?

Are you a werewolf, ghost, vampire or zombie at conferences? Explore the psychology of conference behaviour — and how to avoid becoming a...

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Increasing Complexity of Clinical Study Reports

The world's first human COVID challenge trial has been given the green light

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Plagiarism in Scientific Writing: Lessons Learned

Learn how to avoid plagiarism in scientific writing with practical tips, common pitfalls and proven techniques to protect your work.

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Mentoring – what’s the buzz?

Want a conversation to warm your heart and lift your spirits

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Is Handwriting Better Than Typing for Note Taking and Memory?

Research shows handwriting notes may improve focus and memory compared with typing. Discover why the pen may still outperform the laptop.

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Be 30% more efficient

Metathesiophobia: from Preclinical to Clinical Development

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Three‑Step Hack to Becoming a Conference Superhero

Already surviving conferences as an introvert? Now it's time to thrive. Three advanced techniques to boost your presence, confidence and...

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An Introvert’s Guide to Conferencing for Nerds — Top 10 Tips

Shy, introverted, or just dreading the coffee queue? Practical strategies for scientists and clinicians to network confidently at...

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The Perpetual Grind: Coffee, Science, and the Enduring Search for Health in a Bean

From 17th century coffee houses to modern genetic studies, discover what centuries of research really tell us about coffees health effects...

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The Rise of the Instant Expert in the Age of AI

Explore how AI is reshaping expertise, creating overconfidence, and eroding critical thinking, deep reading, and true understanding.

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Too Many Cooks

Metathesiophobia: from Preclinical to Clinical Development

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The Real Thing

A lot of people say that people don't just buy 'things,' they buy connection

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Update on the Investigator's Brochure

There are many regulatory documents but perhaps none are more critical

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Mentorship in the Age of AI, Remote Work and Gen Z

Explore how remote work and AI are reshaping mentorship and why human connection remains essential for growth and career development.

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Paracelsus and the Origins of Modern Science

How Paracelsus helped shape modern scientific thinking through observation, toxicology, and early chemical medicine.

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How to Respond to Scientific Manuscript Rejection

A practical guide to responding to manuscript rejection with three steps and key tips for revising, rebutting reviewers, and resubmitting...

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Coming to a consensus

Clinical consensus statements are agreed opinions formulated by a group of experts

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Top 5 reasons why bigger isn’t (always) better

The largest pharmaceutical companies not surprisingly rely on the largest contract research organizations

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Titanic clinical protocols

Experience at Niche has taught us that clinical study protocols are born in the white-hot fire

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Critically thinking

Today my son has taken his GCSE exam in Critical Thinking.

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Conference organising 101

They say that as one door closes another one opens.

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Running a Business Without Burning Out

Running a business can be emotionally draining. Learn practical strategies to avoid burnout and protect your health as a leader.

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Mandatory adoption of the European Clinical Trials System approaches

Concerns about readiness of the European Medicines Agency’s (EMA) Clinical Trials Information System persist as the deadline for...

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Mental health and remote working

At the start of the year many of us faced changes to the way we work as the COVID-19

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Five reasons abstracts are important

There is a short summary of a scientific paper called an abstract

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Killing predatory journals…

We all get them, some of us more than 10 a day, emails from journals

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Ready, Aim, Fire!

Metathesiophobia: from Preclinical to Clinical Development

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Pulling the pin...

In the words of Clint Eastwood’s character, Harry Callahan, in the film Magnum Force “A man's got to know his limitations”....

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Association for Human Pharmacology in the Pharmaceutical Industry

The proceedings of the Association for Human Pharmacology in the Pharmaceutical Industry (AHPPI)

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Keep it brief…

Never judge a book by its cover –we know

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Revised FIH EMA Guideline: Opinion reported

The EUropean Federation for Exploratory MEdicines Development (EUFEMED

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Top 6 tips when starting a company

Last week was the 20-year anniversary of my founding Niche Science & Technology Ltd.

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Deep Breath: Issue #7

Welcome to the seventh issue of the Refractory Asthma Stratification Programme (RASP-UK) newsletter

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Hiding not learning

I have never been great at conferences. People don’t believe me but I am painfully shy and far too worried about what people think of me.

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The Evolution of Patient Voice

For much of the twentieth century, patients in clinical research were positioned primarily as subjects of experimentation rather than active...

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Project Tracking: A valued tool for multiple multidisciplinary projects

If you're managing a project, it's important to stay informed about work progress

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Mastering Poster Layout

Know the difference between an eye-catching, action-inspiring poster

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Impact of the COVID-19 pandemic on clinical trial conduct

Early in 2020, COVID-19 was spreading rapidly across the globe.

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Love: an AI's inquiry into the essence of human connection

We recently encouraged writers (of all kinds) in our recent Insider’s Insight to experiment with large language artificial intelligence...

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Good Laboratory Practices?

Do you know what Good Laboratory Practice stands for? In nonclinical animal studies

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Data, data everywhere… far too much to think

Every year, a huge amount of scientific data is released. It's out there, but how do you find it?

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Clinical Trials Day 2023 – Relax!

Music has a remarkable ability to bring people together and permeate

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The Growing Role of Patient-Reported Outcomes in Clinical Study Reports

The world's first human COVID challenge trial has been given the green light

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Severe Asthma, Smarter Decisions: Aligning Objective Assessment with Patient Voices

Biologic therapies for severe asthma, monoclonal antibodies targeting key type‑2 inflammatory pathways.

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Unknown Knowns

We have some strange terms in the pharma industry

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Best presents go beyond the 'big reveal'

Buying Christmas presents for people can be difficult

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Talking Sense About Science

I believed that the central purpose of journalism is to provide the general population

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Typing two spaces...

There are people everywhere who use two spaces after a full-stop.

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Be the cool kid at congress....

Posters are an excellent opportunity to showcase your work

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Are We Living Through a Bad News Event Horizon?

When a country’s economy becomes so dominated by a single export industry

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Website for the Clinical Trials Specialist Degree Apprenticeship goes live

Visit our brand-new website to learn more about our innovative training programme

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Shorter titles get more citations

Titles are the first thing readers see, yet often they are addressed

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Planning your clinical trial: Avoidable mistakes

Clinical trials are not cheap to conduct, and with data integrity

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Is winning (that) important?

Metathesiophobia: from Preclinical to Clinical Development

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Regulating medical devices in the event of a no deal scenario

Metathesiophobia: from Preclinical to Clinical Development

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Creating awesome titles

Creating an awesome title is like bending a straight line into a circle.

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Site selection - getting it right

High functioning investigator sites are essential to the delivery

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Eight tips for writing a press release

At some point, you'll want to share your great projects with your friends

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Creating your best presentation (ever)

We wanted to tell you about our latest Insider’s Insight - Ta dah

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Top 10 tips to writing up your PhD

Writing your PhD thesis can be a once-in-a-lifetime opportunity

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The undiscovered country

The scientific literature comprises scholarly publications that report original

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Looking out for a hero…

We all need heroes - people who can champion our cause - helping the world to understand our rationale

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