When RespiVert approached NST, it was in an exciting position with early phase regulatory work commencing on several clinical programs for multiple different investigational products. However, as a small company, RespiVert required the support of external vendors to provide support for medical writing services and clinical operations. At NST we were excited for the opportunity to support a growing biotechnology company working at the forefront of pulmonary diseases, and the opportunity to work integrally on various aspects of a clinical program.

The Niche Clinical Operations department were involved in clinical project management and study monitoring for many of the early phase I/II studies on a variety of assets.

The medical writing team demonstrated their expertise on a range of different early phase regulatory documents, being involved in the writing, editing and reviewing of CSRs, IBs, protocols and IMPDs. Furthermore, the foundational work on these documents were improved with progressive IB updates and protocol amendments.

Cross collaboration between the Niche departments meant that both medical writers and clinical project managers contributed to the development of deliverables. This multidisciplinary approach helped ensure consistency and expertise throughout the production of SRMs, pre-IND briefing documents, CTA submissions and protocols.

Lastly, the NST team were also involved in providing guidance on internal practices at RespiVert by working closely with their executive team to develop SOPs tailored to their unique clinical circumstances and ambitions.