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Quality Standards

Our Quality Management System

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.

Audit and inspection history

  • Hosted 150+ Sponsor/CRO audits
  • 22 audits hosted in 2018
  • Experienced in hosting regulatory inspections (FDA, EMA, ANVISA)

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:

  • International Council for Harmonization Good Clinical Practice (ICH GCP)
  • Food and Drug Administration (FDA)
  • European Medicines Agency (EMA)
  • Brazilian Health Surveillance Agency (ANVISA)

Learn about our Clinical Trial experience.

Learn more about conducting Clinical Trials with Nucleus Network

 

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