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.
The British Society for Haematology (BSH), the UK’s largest haematology organisation, promotes excellence within the.
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Unit 26 Falstaff House
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