Niche began supporting VectivBio with the apraglutide clinical programme in 2020, writing several clinical study protocols, including a protocol for their pivotal global Phase III trial. Working simultaneously on several study protocols, the Niche team were able to quickly and efficiently familiarise themselves with the details and complexities of the asset and the programme as a whole. This provided an insight which was propagated throughout the duration of the working relationship. As the programme progressed through the clinical development pipeline, services were tailored to meet the differing requirements of the regulatory pathway, including providing various study documents, laboratory manuals, protocol amendments and IB updates. The Niche team worked holistically with VectivBio. Members of the Niche Clinical Operations department worked in tandem with the Medical Writing team to share their clinical knowledge and expertise, ensuring that messaging was consistent.

In 2022, Niche was adopted as the collaborative regulatory vendor for VectivBio. The Niche team provided comprehensive support in developing the Market Application Authorisation for VectivBio’s lead product. The Niche medical writing team were integral to the strategic, temporal and clinical decision-making process, actively involved in delivering CSRs and CTD modules. Day-to-day services provided by the team included coordination, writing and editing of key documents including CTD module 2 documents, meeting summaries, timeline management, style guides and study narratives and IB updates. The team were involved in handling concurrent multidisciplinary reviews. As the submission date approached the team were intimately involved in coordinating document finalisation.