Insider’s Insights

Mastering the complexities of clinical development requires more than just following a manual; it demands the kind of "handy guides" only decades of experience can produce.

Our Insider’s Insights are a curated library of practical wisdom, designed to help you navigate everything from the "necessary evil" of project meetings and the sting of journal rejections to the strategic design of concept protocols. We believe in sharing our hard-earned expertise to elevate the industry as a whole, providing you with the tools to work smarter, ensure regulatory compliance, and move your innovative medicines toward success with confidence.

Explore our collection, sign up for the latest issues, and let our 25+ years of clinical and medical writing experience become your competitive advantage.

Holding a meeting

Meetings are a necessary evil but handled badly they can be a terrible waste of time. We provide insights on conducting successful and effective meetings.

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Handling Rejection

All authors will get some form of rejection from a journal at one time during in their careers. We offer some insights on managing journal submissions successfully.

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Concept Protocols

Concept protocols are short, flexible documents that can be reviewed quickly and edited easily. We provide some insights on their efficient design and use.

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Good publication practice

Being updated

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Targeted Journal Selection

Choosing the wrong journal can result in your publication being delayed. An informed process that targets optimal journal identification will save you time, money and heartache.

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Clinical Study Reports

The clinical study report (CSR) is a crucial document in the drug development and regulatory submission process. We provide key learnings to ensure prompt delivery of high quality CSRs.

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Amazing Abstracts

An abstract is simply a short, standalone summary of your work or paper. Writing abstracts is easy, writing amazing abstracts is not as easy to accomplish. We show you how.

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Poster Presentations

Anyone can read guidelines on what makes a great poster, but can they produce something that looks professional and clearly communicates your message? Niche can and does.

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Better Slide Presentations

Use the right slide design and your whole presentation will come to life. Follow some simple rules and you will create well-designed presentation slides that effectively communicate your message.

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Branding science

A well-chosen name and visual identity for a clinical programme will promote awareness of a clinical intervention and/or practice. We provide here some insights on how.

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Perfect Press Releases

Writing a press release is not difficult, though there are conventions that should be followed if you want your material to attract the attention of gate keepers.

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Plagiarism

The issue of plagiarism is of growing concern within biomedical and life science research. Can you navigate it safely? We advise on how to avoid unwarranted accusations of intellectual theft.

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Training records

Staff working on research studies must be familiar with the requirements of GCP and have up-to-date training records. We provide insights into their content and maintenance.

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Key Opinion Leader Identification

We summarise what do you need to know to ensure that your next search for ‘thought leaders’ is conducted in an appropriate and considered fashion.

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Literature Searches

Your literature search’s quality and value is wholly dependent on the thought and effort you put into developing your search strategy. We show you how to identify the most appropriate references.

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Authorship

Authorship can be a source of unethical behaviour and disputes. We provide guidance on how to navigate the authorship minefield.

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Bibliometrics Breakdown

Do you know your h-index from your m-quotient? Familiarity with bibliometric parameters aids in your assessment of publications. Niche shows you how you may interpret these parameters and employ them effectively.

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Self Promotion

Long gone are the days of publishing your findings in a journal and simply returning to the bench. We are living in the Information Age – we describe key terms that will help you understand the process of self promotion.

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Site Selection

High functioning investigator sites are essential to the delivery of a successful clinical trial. But not all sites seem able to fulfil their study requirements.

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Titles

Titles are the first thing readers see, yet often they are addressed at the end of your project, and just as often are the aspect of your work that is given the least attention.

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PhD

Writing your PhD thesis can be a once-in-a-lifetime opportunity to contribute to your field, relate to your peers with similar interests, and challenge your understanding. While the process is incredibly rewarding, it is best to be appropriately prepared. So we’ve put together a handy guide – so you know exactly what to expect.

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Consensus

Clinical consensus statements reflect opinions drafted by experts for which agreement has been sought on specific clinical challenges. In contrast to clinical practice guidelines, they are more applicable to situations where evidence is limited or lacking, but where there are opportunities to reduce uncertainty and improve quality of care for patients.

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Investigator's Brochure

The Investigator's Brochure is a crucial multidisciplinary document in the drug development and regulatory submission process. We provide key learnings to ensure you delivery of a well-constructed, fully compliant document.

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Responding to Reviewers

A well-constructed response to the reviewers is the key to how well your ‘corrected’ manuscript will be received and whether it will be accepted for publication.

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Organising a Professional Conference

Scientific meetings are at the heart of a scientist’s professional life. The secret behind successful events is a blend of planning and organisation. Crack these and you will be a hard act to follow.

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Grant Applications

Competition for funding is fierce, only a minority of proposals receive support. Grant writing is a skill essential to your average researcher.

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Good Laboratory Practice

Good Laboratory Practice is a quality system for planning, performing, monitoring, recording, reporting and retaining non-clinical studies.

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Case Reports

Case reports are a cornerstone of medical commenting. They typically provide invaluable insight into potentially novel and/or relevant clinical conditions and treatment.

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Awesome Advisory Boards

Advisory boards should not be viewed as a stand-alone event, nor will they necessarily address all aspects of a knowledge gap.

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Investigator Initiated Trials

Investigator initiated trials offer benefits for investigators, patients and pharmaceutical companies, but they also carry risk.

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Artificial Intelligence in Medical Writing

Artificial intelligence has reached a point where non-experts can use them to support their work. Should they?

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Insiders Insight Reviews Guide

The ever-increasing range of scientific knowledge feeds the need for well-conceived reviews that summarise the state-of-play and, through the cited literature, provide an opportunity to dig deeper into the topic of interest.

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Insider's Insight - Look Your Best first page | Niche

Look Your Best

Clear, confident writing is essential in the pharmaceutical industry. This practical guide shows you how to assess and edit your own medical and scientific documents to improve clarity, accuracy and professional impact.

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Healthy Subjects

Defining a “healthy” Phase I participant is more complex than it seems. This guide highlights the key considerations for safe and effective early clinical research.

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