Many of our clients give priority to their clinical objectives, like getting to first-in-human trials or 'starting the next study'. The importance of clearly defining and properly maintaining an appropriate quality environment can easily be overlooked.

As part of our service offering, we provide robust Quality and Vendor Management Systems designed to ensure compliance, mitigate risk, and uphold the highest standards across all outsourced clinical and operational activities. The speed with which we can provide access to our services is critical to supporting biotech and pharmaceutical sponsors in meeting global regulatory expectations and maintaining audit readiness throughout the clinical development lifecycle.

Our Quality Management System (QMS) is built on industry best practices and aligned with ICH-GCP, FDA, EMA, and other international regulatory frameworks. It includes appropriate Standard Operating Procedures, training programs, internal and external audit programs, deviation and CAPA management, and document control for SOPs, quality records, and essential documents within validated systems. Our QMS offering is scalable to meet the specific needs of emerging biotechs or large pharmaceutical clients, with the flexibility to integrate sponsor-specific procedures when required.

Our SOP on 'Production, Review and Approval of Standard Operating Procedures' is available to download here.

The increasing complexity of the clinical operating environment and need for supplier validation places a burden of proof on small team teams. Niche can provide support in the form of evidenced vendor oversite managed by the Niche team to oversee third-party service providers engaged in the trial (e.g., laboratories, courier services, eCOA vendors, data providers). Key elements include:

By combining rigorous quality oversight with structured vendor governance, we enable sponsors to maintain control, transparency, and compliance—reducing operational risk while improving execution efficiency.