Regulatory

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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From a Living Hell to a Licensed Therapy: Niche's Role in the Approval of Waskyra

The EMA has approved Waskyra for Wiskott Aldrich Syndrome. A personal reflection on Niche's decade long role in this gene therapy's...

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A New Era for UK Clinical Trials? Analysing the April 2026 Regulatory Overhaul

The UK's biggest clinical trials reform in 20 years takes effect April 2026. What the new MHRA regulations mean for sponsors and trial...

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Metathesiophobia: from preclinical to clinical development

Having worked in early-stage clinical pharmacology for over 30 years

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A New Era for Severe Asthma: RASP-UK First Publication

The first RASP-UK publication outlines a stratified medicine approach to severe asthma using biomarkers and personalised treatment...

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The European Biotech Act: Implications for Early Clinical Pharmacology and Phase 1 Industry in Europe and the UK

Discover how artificial intelligence is affecting medical writing, where its limits lie, and why human judgement remains critical for...

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The Investigator’s Brochure: Multifaceted and Multidisciplinary

Metathesiophobia: from Preclinical to Clinical Development

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FDA’s Plausible Mechanism Framework for Ultra-Rare Disease Therapies

How the FDA’s Plausible Mechanism Framework could transform personalised genomic therapies and treatment development for ultra-rare...

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The Clinical Study Report

Welcome everyone to the first issue of the Frailomic consortium

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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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Revised FIH EMA Guideline: Opinion reported

The EUropean Federation for Exploratory MEdicines Development (EUFEMED

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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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Infographic showing The Investigator's Brochure: An Insider's Insight with circular diagram depicting clinical trial phases including Study Setup, On Study Management, and Study Close-out sections.

Niche crafted a strategic communications plan for ApaTech's synthetic bone graft portfolio, translating preclinical science into compelling manuscripts, regulatory documents and conference publications ahead of its $330 million acquisition.

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Astex Pharmaceuticals

Niche provided Astex with expert regulatory writing across their oncology pipeline, delivering clinical protocols, study reports and safety narratives largely autonomously and to an exceptionally high standard.

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MID-Frail Study

When the original CRO walked out mid-trial, Niche stepped in to rescue and deliver this EU-funded, 74-site European study on frailty in older adults with type 2 diabetes.

$RASP (Refractory Asthma Stratification Programme) logo with stylised text and geometric design elements$

RASP-UK initiative

Since 2014, Niche has run the executive function of this £9.6 million MRC-funded consortium, overseeing seven clinical trials across 13 academic centres to personalise severe asthma treatment.

Circular diagram showing frailomic and Frailty factors text in centre, surrounded by icons representing medical conditions and health factors in concentric rings.

Niche built and coordinated the full communications strategy for this 20-institution European initiative, turning complex frailty biomarker research into compelling content for academics, policymakers and the public alike.

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