Nucleus Network’s Quality Management System (QMS) is based on Good Clinical Practice (GCP) quality guidelines, regulations, principles and requirements (GxP).
The main priority of the QMS is subject safety and data integrity, enabling sponsors to expedite drug development as they can trust the data is accurate and reliable.
We maintain over 100+ Standard Operating Procedures (SOPs). All our in-house training is implemented utilising a fully validated Learning Management System (LMS).
All Nucleus staff are trained in Good Clinical Practice (GCP) as part of our compulsory employee onboarding and induction processes.
Australian data is accepted for regulatory submissions
The Food and Drug Administration (FDA) and European Medicines Agency (EMA) accept Australian data for regulatory submission. This means data taken from our studies can be used to support international regulatory applications.
Nucleus data is measured against stringent regulatory standards, including:
Learn about our Clinical Trial experience.