Key activities provided by Niche have included over the year of our partnership have included:
"Based on this personal and team experience, I have always been impressed by the standard of the work delivered by the Niche teams. The native English-speaking writers provided confidence in the written documents they produce and fosters clear communication."
Niche began discussing Recardio's clinical aspirations and future requirements in 2017 as the company completed recruitment for the Phase 1 study of dutogliptin, which evaluated safety, pharmacokinetics and pharmacodynamics in healthy volunteers after single and repeated parenteral application. The Niche team provided support services for the development of regulatory documents to support the REC-DUT-002 (Phase 2), a global multicentre, double-blind, randomised, placebo-controlled trial that evaluated the safety and initial efficacy of dutogliptin in co-administration with filgrastim as an adjunct treatment for patients in early recovery following an acute myocardial infarction. This was followed by the HEAL-MI study, a global multicentre, randomised, double-blind, placebo-controlled Phase 3 trial that is evaluating safety and efficacy of dutogliptin in co-administration with filgrastim in early recovery post-myocardial infarction.
When stalled regulatory documentation threatened to derail their neurological programme, Cleothena turned to Niche —.
read moreNiche provided Astex with expert regulatory writing across their oncology pipeline, delivering clinical protocols, study.
read morePutting patients first, Niche supported ViiV Healthcare's global HIV outreach programmes with medical writing,.
read moreNiche delivered rigorous QC and medical writing support across Adaptimmune's full suite of regulatory documents, keeping.
read moreNiche built and coordinated the full communications strategy for this 20-institution European initiative, turning.
read moreAt the height of the pandemic, Niche's rapid manuscript writing helped Synairgen publish their landmark interferon beta.
read moreNiche supported Nabriva's antibiotic lefamulin from early clinical protocols all the way to FDA, EMA and Health Canada.
read moreOver a decade and 20+ guidelines later, Niche remains the BSH's trusted partner for raising haematology care standards.
read moreFor over a decade, Assign DMB relied on Niche as their embedded writing partner, seamlessly converting statistical.
read moreA trusted writing partner to this Belfast-based early-phase CRO for over a decade, Niche turned BioKinetic Europe's.
read moreNiche served as the English-language regulatory writing backbone for this Nordic consultancy, producing IBs, IMPDs and.
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