Quality

At Staburo, quality is embraced in every stage of our data science and clinical research support activities. We are committed to delivering reliable, accurate, and audit-ready data that supports patient safety, data privacy and compliance.

Our robust Quality Management System (QMS) is managed through a validated eQMS tool that allows us to efficiently handle QMS documents’ lifecycle and our employees’ training program.

In this way, we can ensure consistent, controlled, and effective processes across all projects, in compliance with applicable national and international laws, directives, guidelines and regulations such as the European Union (EU), the Code of Federal Regulations (CFR) of the United States, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).

We are also a certified member of BVMA (Bundesverband Medizinischer Auftragsinstitute, German Federal Association of CROs), ensuring our reliability in terms of safety and compliance with regulatory requirements.

We are continuously (re)qualified by our clients and actively participate in their regulatory inspections (if required).

Quality Management Principles

and Key Elements