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

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...

Investigator Initiated Trials

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

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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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.

ApaTech

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.

A green pyramid diagram showing three layers labelled Application, Platform, and Infrastructure, with arrows indicating breadth and niche dimensions.

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.

FRAILomic

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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