Accreditation and Compliance

Committed to quality at every step

Quality is integral to how we deliver bioanalytical services.

Crux Biolabs combines scientific expertise with controlled laboratory processes to support high-quality bioanalytical data for clinical studies. The National Association of Testing Authorities, Australia (NATA) has accredited Crux Biolabs following demonstration of technical competence to operate in accordance with ISO/IEC 17025.

Our clinical work is performed in compliance with applicable requirements of ICH E6 Good Clinical Practice (GCP), WHO Good Clinical Laboratory Practice (GCLP), FDA 21 CFR Part 11, and ALCOA+ data integrity principles.

View our NATA accreditation

Our quality commitment

Quality is embedded throughout the way we work – from study planning and sample handling through to laboratory execution, data review and reporting. We apply documented processes, appropriate scientific oversight and technically competent personnel to support data integrity, traceability and consistent delivery.

Every study has different scientific, operational and regulatory requirements. We work closely with sponsors to understand the intended data use, sample requirements and technical objectives, then apply a fit-for-purpose approach aligned to the study scope.

Accreditation, compliance and accredited capabilities

View our NATA accreditation
Crux Biolabs is NATA-accredited to ISO/IEC 17025:2017 for defined bioanalytical activities. Within this accredited scope, projects are managed in accordance with Good Clinical Laboratory Practice (GCLP) principles interpreted for research.

Our accredited capabilities include:

Pharmacokinetic analysis using electrochemiluminescence (ECL), enzyme-linked immunosorbent assay (ELISA), flow cytometry and LC-MS/MS

Anti-drug antibody measurement using ECL

Cytokine and protein analysis using ECL, ELISA and multiplex bead-array assays

Cell characterisation, identification and isolation using flow cytometry

Isolation and cryopreservation of mononuclear cells, plasma and serum

Nucleic-acid extraction

Accreditation applies to the defined activities and services listed in Crux Biolabs’ NATA Scope of Accreditation. Contact our team to confirm how these capabilities apply to your study requirements.

Independently assessed. Consistently trusted.

Independent assessment of laboratory performance

Crux Biolabs participates in industry proficiency-testing and external quality assurance programs to independently assess selected laboratory methods and support continuous improvement. These programs compare laboratory performance against defined external criteria and peer-participant results, providing an additional measure of technical competence across relevant bioanalytical activities.

Current participation includes:

  • Immunovirology Research Network (IVRN), Australian Centre for HIV and Hepatitis Virology Research: PBMC isolation
  • External Quality Assurance Program Oversight Laboratory (EQAPOL), Duke University: Flow cytometry, MSD and Luminex
  • Royal College of Pathologists of Australasia Quality Assurance Programs (RCPAQAP): DNA extraction, LC-LC/MS and ELISA

Participation in these programs supports our quality system by helping us monitor method performance, identify improvement opportunities and maintain confidence in the consistency of our laboratory processes. Proficiency-testing activities are undertaken for relevant methods and do not extend or replace the defined scope of Crux Biolabs’ NATA accreditation.

OGTR-certified PC2 facility

Crux Biolabs operates a Physical Containment Level 2 (PC2) laboratory certified by Australia’s Office of the Gene Technology Regulator (OGTR). This certification confirms that the facility meets prescribed containment, access, decontamination and operational requirements for authorised work involving eligible genetically modified organisms (GMOs).

For sponsors, our PC2-certified facility provides a controlled environment for eligible GMO and GM-derived material studies. It supports appropriate biosafety and containment practices, trained personnel and documented procedures, helping sponsors progress specialised research activities with confidence.

Quality throughout the study lifecycle

Study planning

We work with sponsors to define technical requirements, sample-handling expectations, study timelines and the intended use of the data. This early alignment supports a clear, practical approach from the outset.

Laboratory execution

Our team performs study activities using documented procedures, appropriate controls and trained personnel. Scientific and operational oversight support consistency and traceability throughout laboratory execution.

Data review and reporting

Data are reviewed in accordance with agreed study requirements before reporting. Clear documentation and communication help ensure data packages are delivered with the context needed to support informed decisions.

Continuous improvement

We review changes, observations and improvement opportunities through controlled processes. This supports ongoing learning while maintaining appropriate oversight of study activities.