
NZCR units provide 81 research beds
Our dosing units in Auckland and Christchurch are located next to major hospitals which provide access to medical support, additional research services, and collaboration with other world-leading researchers.
We also operate two satellite support sites in Hamilton and Wellington, extending our participant recruitment and outpatient visit capacity. Here, we conduct screening, outpatient visits, and in-house lab processing using the same SOPs, training, and oversight as our dosing sites.
NZCR is approved and certified as a clinical research unit by the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) under New Zealand legislation, section 30 of the Medicines Act 1981.
Our dosing units have:
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- Fully equipped emergency trolleys.
- Emergency call system and monitored security systems.
- Emergency generator capable of running all essential services.
- GPS-driven digital clocks.
- GE, ECG cardiac telemetry management systems.
- Integrated IT system with ability for Electronic Data Transfer.
- Clinical trial participants areas with entertainment and recreational facilities.
- Laboratory Sample tracking software.
- Remote monitoring capability.
Our Pharmacy Support
Our pharmacy areas have the following specifications:
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- Secure, access-controlled environment
- Temperature controlled and monitored:
- Fridges and freezers, including -80°C ultra-low temperature storage
- Ambient storage for investigational products
- Clean Rooms/Sterile services:
- Positive pressure clean rooms with Class II biosafety cabinets
- Retention sample storage capability
- Unblinded Areas:
- Access-controlled workspace
- Secure storage for unblinded documents and separate unblinded monitoring areas
Pharmacy services:
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- Consultation and expert advice on pharmacy manual development
- Sourcing of comparator drugs and ancillary materials
- Relabeling for retest extension
- Extensive compounding experience including capsule filling, liquid suspension and aseptic preparations
- IMP quarantined storage and management
- Sterile services
Our Laboratory Support
Our laboratory areas have the following specifications:
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- Secure, access-controlled environment
- Temperature controlled and monitored:
- Laboratory storerooms
- 30°C and -80°C freezers
- Ambient and refrigerated centrifuges, and biosafety cabinets
- Peripheral Blood Mononuclear Cells (PBMC) processing and sample storage facility
Laboratory services:
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- Consultation and expert advice on laboratory manual development.
- Electronic laboratory data transfer
- Barcode laboratory sample tracking
- Onsite PBMC processing
- Expertise in shipment of biological samples to partner laboratories by International Air Transport Association (IATA) trained staff
- Established partnerships with local laboratory for Immuno-assays and flow cytometry
Imaging Services
With our imaging partners, we can provide the following imaging services.
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- CT scan
- MRI, Functional MRI
- DEXA
- Lung function assessment
- Ultrasound
- X-ray
- Bone density scanning
- Nuclear medicine PET / MRE / PDFF
Regulatory Services
New Zealand provides a supportive regulatory environment
New Zealand does not require a New Drug Application (IND) and Clinical Trial Application (CTA). This can provide cost savings and efficiencies.
NZCR has extensive experience in managing the NZ regulatory process and can advise pharmaceutical or sponsoring companies on this process to ensure fast regulatory approval timelines.
All clinical trials conducted in New Zealand which involve an investigational product must be approved by the NZ Ministry of Health; the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) and by the Health and Disability Ethics Committee (HDEC).
Applications are made to both Medsafe and HDEC in parallel via the online forum. The Medsafe application is the responsibility of the local sponsor and the HDEC application is handled by the lead site.
The New Zealand Regulatory Process
New Zealand Medicines and Medical Devices Safety Authority
To conduct a clinical trial in New Zealand requires an application to the New Zealand Medicines and Medical Devices Safety Authority (Medsafe). This committee requires:
- Completed application form
- Trial protocol
- Investigational drug brochure
- Participant information and consent forms
- Indemnity Insurance certificate
- Investigator(s) CV and the investigators’ agreement to conduct the trial
New Zealand Health and Disability Ethics Committee
Clinical trials conducted in NZ also require approval from the New Zealand Health and Disability Ethics Committee (HDEC). This committee requires:
- Completed application form
- Trial protocol
- Investigator’s Brochure
- Participant Information Sheet and Consent Form(s)
- Data and Tissue Management Plan
- Indemnity Insurance certificate
- Advertising
- Investigator(s) CV