clinical research of new zealand

About NZCR & Clinical Trials in Auckland, Hamilton, Wellington and Christchurch

NZCR is New Zealand’s leading early phase clinical research provider.

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NZCR was formed in 2020 by the merger of Auckland Clinical Studies (ACS) and Christchurch Clinical Studies Trust (CCST), and is New Zealand’s leading early phase stage clinical research provider.

The merger brings together over 35 years combined research excellence, a track record of completing over 750 trials involving over 15,000 participants and provides expanded scale and capability.

With physician led, world class research units located in Auckland, Christchurch, Wellington, and Hamilton, NZCR  conducts complex early phase clinical research in healthy participant and patient populations.

We partner with global pharmaceutical and biotechnology companies to deliver excellence in clinical research and investigate potential new medicines by conducting clinical studies in Auckland, Hamilton, Wellington, and Christchurch.

NZCR values the key role of our study participants in clinical research. We provide detailed study information, expert clinical care, and support services to ensure the safety and comfort of all our participants. Clinical study participants are compensated for their time and travel.

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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.

Christchurch

Our Mission

The Medical Research Institute of New Zealand (MRINZ) is Aotearoa New Zealand’s leading independent medical research institute.

Our research is guided by a simple philosophy: it must challenge dogma, increase knowledge, and have the potential to improve clinical practice and outcomes, both in Aotearoa New Zealand, and internationally.

The MRINZ’s research teams are dedicated to investigating important public health problems, delivering high quality evidence on which to improve the management of disease and patient care.

An internationally recognised academic institution, the MRINZ is a registered charitable trust, pursuing advances in clinical practice and providing a base for specialist training in medical research.

Guiding Principles

Independence and impartiality.

The MRINZ is an independent research institute and a registered charity ( ID CC22439 ). This independence allows us to conduct our research free from external influences, such as from industry and government. 

Commitment to Equity and Te Tiriti o Waitangi

Committed to contributing toward a more equitable society that respects Te Ao Māori and upholds Te Tiriti o Waitangi, the MRINZ is working to support tangata whenua-led processes, where Māori worldviews and values help shape our research.

Impact and Capability

We currently publish an average of 75 peer-reviewed publications each year, and our work has contributed to significant changes in medical practice globally. Our ability to function as an independent trial coordinating centre enables us to achieve this high output. This extends to both local and large-scale multinational clinical trials, leveraging our capability through extensive research networks in intensive care, hospitals, general practice, and pharmacies.

Transformation and Implementation

Our research is driven by the potential to improve and innovate clinical practice. Consequently, our studies have played a pivotal role in advancing care across multiple medical fields. We have authored and contributed to numerous treatment guidelines, ensuring our findings directly influence and improve patient care here at home and globally.

Training and Education

We are authorised by the New Zealand Qualifications Authority (NZQA) to award our own Medical Doctorate (MD) degree. This degree represents the core of our postgraduate training programmes which include PhD, Masters, and Diploma degrees, in collaboration with Te Herenga Waka—Victoria University of Wellington and University of Otago—Ōtākou Whakaihu Waka.

Our History

Since its establishment in December 2001 the MRINZ has dedicated more than two decades to investigating the causes of important public health problems, and using this knowledge to improve the prevention and treatment of a wide range of diseases.

The MRINZ has been at the forefront of many ground-breaking studies and clinical trials, providing valuable knowledge to the medical community both here at home in New Zealand, and globally.

Beyond research, MRINZ has played a crucial role in providing an established base for specialist training in medical research. Through collaborations with leading universities and institutions both nationally and internationally, MRINZ has facilitated practical clinical research experience and training opportunities for aspiring researchers and healthcare professionals, furthering the advancement of medical knowledge and patient care.

Performance and Impact

The mrinz explores critical issues in public health and clinical practice, challenging dogma, and generating valuable evidence to improve disease management and patient well-being..

Through national and international collaboration, our research has resulted in a substantial body of work with over 900 publications to date, contributing to advancements in clinical practice and management guidelines globally.

In 2023, the MRINZ had its research performance assessed using SciVal, a global database for research metrics. This evaluation compared MRINZ performance with universities and research institutions worldwide, focusing on two key metrics:

Field-Weighted Citation Impact: This measures how often MRINZ research papers are cited by others, adjusted for different citation habits across academic fields. A higher score reflects more significant impact.

Publications in Top 10% Journals by SJR: This shows the proportion of MRINZ research published in highly influential journals.

The analysis covered the five years up to 2023, excluding the latest year for accurate indexing. Results revealed that the MRINZ surpassed all eight New Zealand universities in citation impact and publications in the highest ranked journals. Our citation impact exceeded that of the top five universities globally, as per the Times 2021 ranking, underscoring our strong international impact and leading position internationally.

Facilities and Networks

Our robust clinical research infrastructure and networks enable us to conduct impactful research across various medical fields.  , our home base.

The Institute’s main offices and clinical research facility are housed at Wellington Regional Hospital, Te Whanganui-a-Tara. Wellington Regional Hospital also provides access to a four-bed Te Whatu Ora – Capital, Coast and Hutt Valley Clinical Trials Unit for inpatient studies. 

Collaborative Community Networks

The MRINZ works in partnership with community health spaces such as the Maraeroa Marae Health Clinic and Papakura Marae Health Clinic ensuring that research initiatives are culturally responsive, community-centred, and effectively address the health needs of a diverse population.

Other Trial Groups

The MRINZ is the New Zealand coordinating management centre for a number of significant clinical trial groups, including:

The Australian and New Zealand Intensive Care Society Clinical Trials Group

The New Zealand Cardiothoracic Surgery Network

The New Zealand Respiratory Clinical Trials Group

The New Zealand Rehabilitation Research Group.

Pharmacy Research Network (PRN)

The PRN connects pharmacies throughout New Zealand and Australia, streamlining large-scale Randomised Controlled Trials (RCTs) in community settings.

Primary Care Network

The Primary care network comprises General Practices and independent Clinical Trials Units across New Zealand, dedicated to coordinating healthcare research within community healthcare environments.

Data Management Standards

At the mrinz, we leverage cutting-edge information technology and adhere to stringent data management standards to ensure the integrity and reliability of our research findings.  .

Standards Compliance

Our data management protocols adhere strictly to CDISC (Clinical Data Interchange Standards Consortium) and MedDRA (Medical Dictionary for Regulatory Activities) standards, ensuring consistency, accuracy, and compatibility across datasets.

ECRIN Accreditation

MRINZ is actively pursuing accreditation from ECRIN (European Clinical Research Infrastructure Network), a testament to our commitment to maintaining the highest standards of research excellence and data management practices.

By employingrobust data management strategies and complying with international standards, we strive to uphold the integrity and quality of our research outcomes, ultimately benefiting both scientific advancement and patient care.

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Health research saves lives

Here at the Health Research Council of New Zealand, we support high-quality, high-impact research by investing in People, Ideas and Priorities.

Want to know what the HRC is investing in?

Funding for community-led research available now

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Celebrating 30 years of health achievements.

Find out how the HRC is helping to advance Māori health

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Study to help more NZ cancer patients access clinical trials remotely

Supporting collaborative research between New Zealand and China

Have your say on how the HRC’s Standing Committee for Therapeutic Trials runs

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Aotearoa Clinical Trials is a network of hospital based clinical trial sites with over 20 years experience in clinical trials in Aotearoa - New Zealand

We achieve fast, high quality outcomes

Investigators

We partner with you in the delivery of outstanding quality research.

Participants

Clinical trials may help you - it will certainly help future generations.

Recruiting trials

A list of all current trials being conducted at Aotearoa Clinical Trials

Trial Sites

ACTT operates at multiple sites based in New Zealand Hospitals

Areas of Interest

A list of therapeutic areas and specialist investigators involved

Reach out to one of our team members

By working closely with partners right across the New Zealand health sector, we create greater insight into improved disease management as well as more equitable access to innovative healthcare.

International Certification

Aoteoroa Clinical Trials is the FIRST clinical trial site network in New Zealand to achieve GCSA Certification - the Global Quality Standard for Clinical Research Sites and IAOCR Workforce  Quality Accreditation (WQA). These awards acknowledge ACTT as a centre of excellence for clinical trials.

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How do clinical trials work in New Zealand?

Information on ethics process, principles of research conduct, regulatory considerations, and research governance.

Researchers initiating clinical trials in New Zealand must take into consideration trial protocol and/or design, resource issues, ethics review, regulatory oversight, institutional policies, research governance and many other issues.

Standardised Indemnity and Compensation Agreements (sICA) have been developed by the New Zealand Association of Clinical Research (NZACRes) and are widely used within the New Zealand clinical trial industry. You can access sICA templates on the NZACRes website .

New Zealand has a world-class record of accomplishment with early phase and proof of concept trials validated by independent, clean and accurate clinical data. Overview of New Zealand Regulatory Enivronment

Medsafe is the Medicines and Medical Devices Regulatory Authority for New Zealand. Medsafe administers the regulatory application for clinical trials under Section 30 of the Medicines Act 1981, involving the use of new medicines, unregistered medicines, scientific assessment of gene technology and medical devices. Approvals are issued by Medsafe under a delegation from the Director-General of Health. Medsafe receives and processes applications, liaises with the relevant Health Research Council committee (Standing Committee on Therapeutic Trials (SCOTT) or Gene Technology Advisory Committee (GTAC)) and the applicant, and issues approval letters as part of the approval scheme for clinical trials. Further information about the scheme can be found in the Guideline on the Regulation of Therapeutic Products in New Zealand – Part 11: Clinical Trials – Regulatory Approval and Good Clinical Practice Requirements. You can find the current regulatory guidance on the Medsafe website. One component of the clinical trials scheme is the self-certification of sites that have study participants in residence while the clinical trial medicines are administered. Further information about the self-certification scheme can be found in Section 4 of the Guideline. A list of sites for which self-certification has been lodged with Medsafe can be reviewed on the Medsafe website.

Section 30 of the Medicines Act 1981 authorises the Director-General of Health to approve a clinical trial involving the use of new and unregistered medicines on the recommendation of the Health Research Council of New Zealand (HRC). The HRC maintains two standing committees to consider clinical trial applications and make recommendations to the Director-General. The Standing Committee on Therapeutic Trials (SCOTT) considers applications for new pharmaceutical-type medicines, and the Gene Technology Advisory Committee (GTAC) considers applications for trials involving new and unregistered gene and other biotechnology therapies. The Terms of Reference for these committees are published on the HRC website . The sponsor of a clinical trial should read these documents before submitting a regulatory approval application, as they provide guidance on the committee processes and the data requirements for applications to be considered by each committee.

Ethics committee approval is a separate process from regulatory approval under Section 30 of the Medicines Act 1981 and is not administered by Medsafe. The New Zealand Health and Disability Ethics Committee (HDEC) administers the ethics approval system, which applies to interventional clinical trials regardless of whether they are trials that require approval under Section 30 of the Medicines Act. Clinical trials that require sample collection and storage, or the use of disclosure of health information are in most cases also subject to ethics approval. In New Zealand only one ethics committee review is required per trial, and this covers all sites. Requirements relating to New Zealand HDEC approval of clinical trials are provided on the New Zealand HDEC website. Locality Authorisation for Ethics The term “Locality Authorisation” refers specifically to the process used by the NZ Health and Disability Ethics Committees (HDECs) for ascertaining that all local governance issues have been addressed at sites participating in a clinical trial. Locality Authorisation approval is required by all sites. To gain full approval for a clinical trial, an application requires approval from HDEC plus a Locality Authorisation. Guides, templates, and forms can be found on the HDEC website.

A national costing tool has been developed by the New Zealand Association of Clinical Research (NZACRes) and is widely used by sites to facilitate accurate and transparent trial costing and to support transparent price discussions. You can access the costing tool on the NZACRes website .

The Medicines Act 1981*, Misuse of Drugs Act 1975, and other legislation control the supply of medicines and medical devices in New Zealand. Ministry of Health approval is required for a trial before medicines can be imported into New Zealand. Detailed information about New Zealand’s medicine control requirements and relevant legislation can be found on the Ministry of Health’s website . Regulatory guidance for importing medical devices into New Zealand can be found on Medsafe’s website. ‍ *Note: The Therapeutic Products Bill passed Parliament in July 2023 and became the Therapeutic Products Act (2023). You can follow updates on regulatory changes here.

In accordance with Section 30 of the Medicines Act 1981, an application for a clinical trial of a new or unregistered medicine for approval for distribution in New Zealand must be lodged by, or in the name of, a person or company residing in New Zealand. Further guidance is also available in Section 3.3 of the Medsafe Guideline on the Regulation of Therapeutic Products in New Zealand .

All imports into New Zealand are subject to the Ministry for Primary Industries (MPI) and New Zealand Customs Import regulations. Detailed information about New Zealand’s importing requirements can be found on the MPI website. You can read more about materials shipping on the NZ Association of Clinical Research (NZACRes) website.

The aim is to provide accurate and balanced information for patients.  The focus of discussions should be to raise awareness of clinical trials and discuss the risks and benefits of participation. This is to ensure that patients can make a fully informed decision on participation in a clinical trial study. A Patient Information Form and Consent Form must be provided to the potential participant and completed. You can access templates on the HEDC website.

From 1 January 2011 all clinical trials conducted in New Zealand are expected to be conducted in accordance with the Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95). This applies whether or not approval under the Medicines Act 1981 is required for the trial. In some cases, requirements set out in CPMP/ICH/135/95 do not cover or conflict with provisions in the Medicines Act or in other relevant New Zealand legislation (e.g. legislation relating to reporting requirements or the retention of records). For this reason, some of the requirements specified in CPMP/ICH/135/95 must be modified to achieve compliance with New Zealand law. ‍ Medsafe Guideline on the Regulation of Therapeutic Products in New Zealand.

Medical device developers looking for a rapid, cost effective means of gaining early proof of concept for their products should consider conducting their initial clinical trials in New Zealand. The simple, one ethics committee approval process in New Zealand does not currently require U.S FDA Investigational Device Exemption (IDE) filing prior to the start of the study. More information on Medical Devices – Regulatory Guidance on the Medsafe website.

Standardised Clinical Trial Research Agreements (sCTRA) have been developed by the New Zealand Association of Clinical Research (NZACRes) and are widely used within the New Zealand clinical trial industry. You can access sCTRA templates on the NZACRes website .

In July 2022, New Zealand’s, twenty District Health Boards (DHBs) were disestablished. To begin reforming the health system , the DHBs’ functions were merged into Te Whatu Ora – Health New Zealand, which now leads the day-to-day running of the system for the whole country. Te Whatu Ora also assumed the operational functions of the Ministry of Health, such as managing national contracts. An interim Māori Health Authority was also established in September 2021, ahead of the creation of Te Aka Whai Ora – Māori Health Authority as an autonomous legal entity in July 2022. Te Aka Whai Ora’s role is to provide a more consistent, national leadership of health service delivery with a Te Ao Māori perspective. New Zealanders receive healthcare through a mixture of private and publicly funded services. The public healthcare system is primarily funded through general taxation and is therefore only available to NZ residents.New Zealand’s districts range in population size from approximately 30,000 at the smallest to over 500,000 at the largest. There are currently over 150 hospitals listed as certified providers (private and public) in New Zealand. You can view certified provider maps on the Ministry of Health website . ‍ Te Whatu Ora regions and Public Academic Tertiary Institutions have a research office or similar. The research offices facilitate close working relationships between researchers, clinical staff, ethics committees, funding bodies and commercial sponsors.  These offices act as the central entry point for the approval of research and ensures that governing policies and procedure are adhered to. Contact details for certified clinical trial sites can be found on the Medsafe website.

All research involving Te Whatu Ora – Health New Zealand sites must receive approval from the relevant Research Review Committee before commencing. The relevant Te Whatu Ora site’s Research Office registers the project and organises the review process. ‍ The approval process will involve: • Research Office Application Form • Protocol • Ethics Application • Research Budget • Participant Information Sheets and Consent Forms • Contract or Clinical Trial Agreement • Indemnity and Compensation Agreement • Investigator Brochure • Funding Letter • Evidence of consultation with Māori • Locality Authorisation for Ethics • Scientific peer review • Ethics Approval Letter You can review an example approval process on the Te Whatu Ora – Te Toka Tumai Auckland (previously Auckland DHB) site.

As part of conducting research within Te Whatu Ora – Health New Zealand, an applicant must demonstrate responsiveness to Māori. The Research Application has a section titled Responsiveness to Māori which must be completed for all projects. In most cases, the review is performed either by the Māori Advisor for Research or a similar entity. The Te Whatu Ora Research Office facilitates the review. On completion of the Māori research assessment, a letter of support will be sent to you showing that a process of formal research review has taken place.

NZ Glossary

Use the below to search through some NZ-specific clinical terms. The clinicaltrials.gov site provides a comprehensive glossary of common site terms.

The Accident Compensation Corporation (ACC) provides comprehensive, no-fault personal injury cover for all New Zealand residents and visitors to New Zealand.

Online registry of clinical trials being undertaken in Australia, New Zealand and elsewhere.

ANZCTR website

Any change to the terms of a study, including to the protocol or other supporting documentation, made after a Health and Disability Ethics Committee has approved the study.

A group of independent scientists who monitor the safety and scientific integrity of a clinical trial. The group can recommend to the study sponsor that the study be stopped if it is not effective, if it is causing harm to participants, or if it is not likely to serve its scientific purpose. Committee members are chosen based on the scientific skills and knowledge needed to monitor the particular study. Also referred to as a Data Safety and Monitoring Board (DSMB).

The Gene Technology Advisory Committee provides regulatory review of genetically modified products.

The process by which a Health and Disability Ethics Committee (HDEC) checks, in accordance with the Standard Operating Procedures, that a new application (or substantial amendment to a previously approved application) meets or exceeds established ethical standards.

The Health Research Council is the agency responsible for managing the Government’s investment in health research. The HRC’s committees provide advice on gene technology, accredit health and disability ethics committees and institutional ethics committees, monitor the safety of large clinical trials and review applications to use new medicines in trials.

The Health Research Council website

The Health Research Council Ethics Committee ensure that independent ethical assessment of any proposed research submitted for a Health Research Council (HRC) grant has been carried out either by the HRCEC itself, or an ethics committee approved by the HRCEC. The HRCEC approves ethics committees to carry out this function.

An organisation responsible for a hospital, health centre, surgery or other establishment or facility in New Zealand at or from which the procedures outlined in the protocol of a study are to be conducted.

‘Locality review’ is the process by which a locality assesses its suitability for the safe and effective conduct of an intervention study.

New Zealand Medicines and Medical Devices Safety Authority

SCOTT is the Standing Committee on Therapeutic Trials; a standing committee of the Health Research Council (HRC) whose function is to make recommendations to Medsafe regarding the approval of clinical trials of new medicines under section 30 of the Medicines Act 1981.

An administrative check carried out by the  Health and Disability Ethics Committee (HDEC) secretariat to verify that an application or other item of business is complete and may be assigned for review through the full or expedited review pathway.

Case studies

To illustrate some clinical trial journeys with links to supporting material, we've put together two fictional case studies for example health innovations in collaboration with the New Zealand Association of Clinical Research (NZACRes), Te Tītoki Mataora and the National Institute of Health Innovation (NIHI).

Articles, commentary and blogs

Phase I Pharmaceutical: Psoriasis Treatment

Learn more about how a new treatment for psoriasis could navigate the Phase I clinical trial process, with links to further reading on the discussed topics.

Class II Medical Device: Diabetes Monitoring

Learn more about the clinical investigation process for a wearable diabetes monitoring device, with links to further reading on the discussed topics.

Connecting with the clinical trials sector in New Zealand

Search the HealthTech Activator (HTA) directory for listed clinical trials sites and supporting bodies.

Clinical Research Trials New Zealand

Our experienced team is committed to conducting world-class clinical trials across a wide range of therapeutic areas to enhance the health and wellbeing of our diverse population.

Stemming from one vision, our team is made up of a diverse group of doctors and medical professionals with experience in running clinical trials since 2002. Our team is dedicated to improving and enhancing the health and well-being of our diverse population.

Rosie Mckellar

Sjaan Evans

Kacey Murphy

Director of Business Development

Julia Howell

Strategic Advisor

How We Help​

Taking advantage of the diverse landscape and population of new zealand, pcrn provides unique opportunities for innovative treatment. to continue innovating in medicine, our clinical trials play a pivotal role in presenting new information and data..

Why Should I Volunteer?

Pcrn’s trials are committed to facilitating the availability of new medication for people to live fully with the best quality of life. your participation not only positively impacts you but also those struggling with a disease that affects every facet of their life. medical advancements need participants to continue with healthcare innovation., sponsors & partners, we’re proud to work with:.

Be A Part Of Medical Innovation ​

Volunteer for a trial to b e a part of medical  innovation that helps people’s lives.  See what’s been done and discover what you can do next.

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