Pulmocide first approached Niche in 2016 for support their first regulatory documents to speed up preparation of their first-in-human CTA submission.This involved not only developing the study protocol but also the Investigator's Brochure (IB), Investigational Medicinal Product Dossier (IMPD), and many other other necessary study documents. The medical writing team subsequently supported several of Pulmocide’s programmes, providing writing, editorial, reviewing and quality checking services on IMPDs, IBs, CSRs, DSURs and protocols. By employing a dedicated medical writing vendor early in the development programme, the team were able to not only deliver high quality documents on time and within budget, but were also familiar with the underlying science and clinical challenges, resulting in efficient and effective handling of updates and amendments.

Following the first successful clinical trial application to the MHRA, Pulmocide continued to take advantage of NST's collaborative nature, with both parties working in tandem to support the Pulmocide’s clinical programme. Pulmocide engaged NST's Clinical Operations team to operationalise their clinical programmes. The NST team was involved in coordinating several successful CTA submissions to the MHRA. Moreover, the in-house knowledge and experience gained on Pulmocide’s clinical programmes meant that subsequent regulatory requests were tackled efficiently. The Pulmocide team concluded that they benefitted greatly from the partnership - with the NST team quickly becoming familiar and experienced with Pulmocide’s methods of working and their strategic ambitions and messages. Projects were completed within budget, with deadlines and timelines met in an efficient manner.