Regulatory

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 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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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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The Investigator’s Brochure: Multifaceted and Multidisciplinary

Metathesiophobia: from Preclinical to Clinical Development

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

The first publication to come out of our UK Refractory Asthma

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The Clinical Study Report

Welcome everyone to the first issue of the Frailomic consortium

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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.

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.

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-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.

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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