Case Histories

Niche delivered rigorous QC and medical writing support across Adaptimmune's full suite of regulatory documents, keeping pace with ambitious timelines on multiple TCR-based cancer therapy assets simultaneously.

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.

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.

Over a decade and 20+ guidelines later, Niche remains the BSH's trusted partner for raising haematology care standards through literature reviews, writing support and audit documentation.

A partnership born in 2002, Niche has supported Cardionetics across medical writing, regulatory strategy and product value assessment for their pioneering ECG arrhythmia detection devices.

When stalled regulatory documentation threatened to derail their neurological programme, Cleothena turned to Niche — who delivered standout clinical protocols and an Investigator's Brochure with minimal client input.

Niche provided DemeRx with end-to-end support to launch a pioneering ibogaine addiction trial, covering site identification, regulatory submissions, and interim medical leadership.

Niche partnered with Erytech Pharma to rescue and rewrite substandard clinical study reports, delivering a high-quality regulatory package in support of their oncology BLA submission.

When an Alzheimer's programme hit a wall after two negative Phase III trials, EVERSANA called on Niche to make sense of the data and chart a credible path forward with regulators.

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.

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.

Niche supported Nabriva's antibiotic lefamulin from early clinical protocols all the way to FDA, EMA and Health Canada approval — a decade-long writing partnership with a genuinely world-changing outcome.

Niche played a foundational role in securing EMA approval for Strimvelis, the world's first ex vivo autologous gene therapy, and continues supporting Orchard's pioneering rare disease pipeline.

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.

From Phase 2 through to the global Phase 3 HEAL-MI trial, Niche has been Recardio's trusted writing and regulatory partner in advancing dutogliptin as a cardiac regeneration therapy.

Niche supported ReCode Therapeutics in launching their first UK patient study, delivering end-to-end clinical and regulatory operations for pioneering mRNA and gene correction therapies.

Trusted as Legal Representative and on-the-ground CRO, Niche became integral to Surface Logix's EU clinical team, delivering four trials across three assets in just 24 months.

At the height of the pandemic, Niche's rapid manuscript writing helped Synairgen publish their landmark interferon beta COVID-19 trial results, unlocking the company's largest ever fundraising round.

Putting patients first, Niche supported ViiV Healthcare's global HIV outreach programmes with medical writing, communications planning and bespoke research into worldwide access to HIV medicines.

For over a decade, Assign DMB relied on Niche as their embedded writing partner, seamlessly converting statistical outputs into polished clinical study reports across oncology, asthma and gastroenterology.

A trusted writing partner to this Belfast-based early-phase CRO for over a decade, Niche turned BioKinetic Europe's clinical outputs into polished study reports across oncology, asthma and gastroenterology.

Chosen as FDL's UK regulatory and clinical operations partner, Niche managed three Phase 1a/b cystic fibrosis studies from MHRA submission to closeout with every CTA accepted without major comment.

The clinical evidence Niche helped generate for Funxional's novel anti-inflammatory compound FX125L proved compelling enough to attract Boehringer Ingelheim, who acquired the entire BSCI programme in 2012.

Embedded in HMR's early-phase work since 2005, Niche has supported their specialist Phase I and II trials with monitoring, CTA submissions, medical writing and pharmacovigilance across multiple therapy areas.

Niche prepared the full regulatory package for HOOKIPA's groundbreaking arenavirus immunotherapy platform, enabling the world's first first-in-human studies of an LCMV-based vaccination vector with a positive health authority outcome.

What began as a CSR writing request grew into a broad regulatory partnership, with Niche guiding iOnctura's roginolisib programme through ILAP designation, Orphan Drug status and US IND submissions.

Regulatory documentation, ILAP designation and a robust clinical protocol for the Sunlight Trial — Niche helped Nanomerics take their innovative tacrolimus eye drop reformulation all the way to first-in-human.

At the height of the COVID-19 pandemic, Petrovax called on Niche to build a strategic communications plan positioning their vaccine and immunology portfolio for maximum global scientific impact.

Brought in from the very first CTA submission, Niche grew into Pulmocide's fully embedded clinical and regulatory partner, covering everything from medical writing and study monitoring to pharmacovigilance.

Niche functioned as RespiVert's extended clinical and writing team across multiple early-phase respiratory programmes, contributing to the work that ultimately helped position the company for its acquisition by Johnson & Johnson.

Niche served as the English-language regulatory writing backbone for this Nordic consultancy, producing IBs, IMPDs and scientific advice documents for MHRA and BfArM submissions across multiple programmes.

Chosen for their Phase I first-in-human UK debut, Niche acts as Sorriso's Legal Representative, keeping the study on track through regular oversight, monitoring reviews and agency communications.

Working from poor quality hard copy source materials, Niche rescued and rebuilt Thromboserin's Investigator's Brochure for TH001, laying the regulatory foundation for their anti-thrombotic clinical programme.

From Phase I protocols to a full Marketing Authorisation Application, Niche was VectivBio's embedded regulatory writing partner throughout apraglutide's development, contributing to the programme that attracted Ironwood Pharmaceuticals' acquisition.