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New Zealand Clinical Research conducts complex early-phase clinical trials involving both healthy participant and patient populations from our state-of-the-art research units located in Auckland and Christchurch, New Zealand.
Our location close to major teaching hospitals provides access to medical support, additional research services and collaboration with world – leading researchers.
NZCR is approved and certified as a clinical research unit by Medsafe under New Zealand legislation (Section 30 of the Medicines Act 1981).
Both our units have:
Our units have the following configurations.
With our imaging partners, we can provide the following imaging services.
New Zealand does not require a New Drug Application (IND) and Clinical Trial Application (CTA). This can provide cost savings and related 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.
Read more below
Any clinical trials conducted in New Zealand must receive approval from the NZ Ministry of Health (Medsafe) committee SCOTT (Standing Committee on Therapeutic Trials). An application is made to the SCOTT committee via an on-line process. After this approval, the trial must be approved by a NZ Health and Disability Ethics Committee. The SCOTT and Health and Disability Ethics Committee regulatory processes run in parallel.
New Zealand Regulatory Processes and Timelines
Average timelines from submission to approval is 4 – 6 weeks (depending on trial complexity).
Further information on the NZ Regulatory Process. READ more
The first step in achieving approval to conduct a clinical trial in New Zealand is an application to the SCOTT (Standing Committee on Therapeutic Trials) committee.
This committee requires:
The SCOTT committee is administered by Medsafe.
Medsafe notify the applicant of the committee’s decision within 45 days of receiving the application.
Clinical trials conducted in NZ also require approval from a New Zealand Health and Disability Ethics Committee (HDEC). NZCR makes this application for approval by one of four HDEC committees for all trials it proposes to conduct.
NZ Ethics Committees has four ethics committees which meet every week.
Applications close two weeks prior to the meeting date.
Meeting dates can be provided upon request
The information required by the committees includes:
New Zealand Clinical Research (NZCR) provides state of the art research facilities and the expertise to conduct complex early phase clinical research in healthy participant and patient populations.