DemeRx, a newly established biotech company with a promising innovative medicine in development found its progress delayed—not due to scientific limitations, but because of the pressing need for identifying a Phase I site the conduct their study and robust, high-quality regulatory documentation for the trial submission. The solution to DemRx’s dilemmas to engage Niche as a service provider known for its agility, strong relationship with most of the UK's Phase I sites and a deep regulatory expertise. Through rapid contracting and seamless onboarding, Niche was able to quickly mobilise a skilled team that immediately grasped the nuances of DemeRx's requirements.

In addition to operational and regulatory support, Niche provided strategic oversight to ensure trial quality and compliance throughout the study lifecycle. This included establishing a clinical monitoring plan, coordinating on-site activities, and providing ongoing quality assurance. Responding to a gap in DemeRX’s leadership structure, Niche also assisted in the successful identification and onboarding of an interim Chief Medical Officer, ensuring continuity of medical oversight and regulatory representation. The end-to-end support offered by Niche not only de-risked the study’s start-up phase but also strengthened DemeRX’s clinical infrastructure during a critical stage of development.