Information for Sponsors

and Researchers

New Zealand has become a very desirable location for conducting clinical trials because of the quality of its health care professionals, the smooth and centralised ethics and regulatory processes, and the reliable and timely recruitment that can usually be accomplished.

P3 Research has two clinical trial sites, in Wellington and Tauranga, and has an international reputation for providing high quality clinical data within short time-scales. As an independent company, we are able to process study applications quickly which, coupled with the centralised regulatory processes in NZ, ensures that start-up times are minimised.

Our experienced medical and nursing staff review all study proposals and provide rapid feedback on safety and logistical issues and anticipated recruitment. Where appropriate, specialist advice from medical opinion leaders can also be obtained.

We have extensive experience acquired over 12 years with phase 2 and 3 trials in many therapeutic areas but have particular expertise with asthma, COPD, vaccine and Type 2 diabetes research. We have worked extensively with most major Pharma both directly and/or through CROs.

Specialist techniques include: allergen and bronchoconstrictor challenge tests, sputum induction and processing and plethysmography. Our private room facilities are suitable for even those studies requiring serial assessments over a full-day or, for up to 48 hours.

P3 Research has developed a robust SOP system which, combined with our internal quality systems, assures that clinical studies are performed to a consistently high standard.

Ethics Committees

The Ethics review process in New Zealand is undertaken by any one of five Health and Disability Ethics Committees (HDECs). The process is centralized and involves on-line submission and correspondence. There is a meeting of at least one committee every week and application may be made to any one of the committees.  There is no charge for review by an HDEC in NZ and they are required to respond within set timelines.

As part of the application process consultation must be undertaken with a local Maori consultation group. Maori are the indigenous people of New Zealand and have some specific issues that need to be addressed by those performing clinical research. P3 Research has established relationships with local Maori consultation groups and will apply for support on behalf of the Sponsor. This process does not delay HDEC approval.

P3 Research has extensive experience in filing ethics applications. If you would like more information about this process please contact us.





 
Regulatory Authority

The Regulatory Authority in New Zealand is Medsafe which is governed by the Ministry of Health. Prior to conducting a clinical trial involving a non-licenced product, or a licenced product for a new indication or using different dosing regimes, an application must be submitted to Medsafe. An application must also be made to SCOTT (Standing Committee on Therapeutic Trials). These applications can run at the same time as that to the HDEC.

Applications to Medsafe / SCOTT are the responsibility of the Sponsor but may be delegated to a New Zealand based representative. The current fee schedule may be found here.

 



New Zealand Regulations

Current guidelines for conduct of clinical research are defined in "New Zealand Regulatory Guidelines for Medicines". These guidelines are available in full on the Medsafe website. Please note that updated guidelines came into effect on 01 January 2011. For further information please refer to the Medsafe web-site.

 

 

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