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Information for Sponsors and Researchers
P3 Research
P3 Research has developed an International reputation for providing high quality clinical data within short time-scales. Being an independent company, we are able to process study applications quickly to ensure that approval times are minimised.
Our experienced medical 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 may also be obtained.
We have experience conducting research in many therapeutic areas with extensive experience in asthma and COPD research. Specialist techniques include: allergen and bronchoconstrictor challenge tests, sputum induction and processing and plethysmography. We are also able to undertake studies requiring full-day or overnight respiratory assessments.
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.
If you would like more infomation about clinical research at P3 Research please contact Dr John Gillies.
Before conducting a study approval must first be sought from an Independent Ethics Committee. In New Zealand, there are 7 Health and Disability Ethics Committees; the choice of Committee will depend on where the study will be run. For single centre trials, or trials involving more that one site within the same region, an application must be made to the local Committee. For studies involving multiple sites in different regions an application must be made to the Multi-region Ethics Committee based in Wellington.
Committees meet at least monthly and approval may be obtained within 2-4 weeks of the application being reviewed. Please click here tor the Ethics Committees Meeting Dates.
As part of the application process a letter of support must also be obtained from a local Maori consultation group. Maori are the indigenous people of New Zealand and they have specific issues that need to be addressed when performing clinical research. P3 Research have established relationships with local consultation groups and will apply for support on behalf of the Sponsor.
Ethics Committees in New Zealand do not charge a fee.
More information about the New Zealand Ethics Committees can be found here.
P3 Research has extensive experience in filing ethics applications. If you would like more information about this process please contact Jeannette Woodman.
Regulatory Authority
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Please click here for the NZ guidelines and Medsafe / SCOTT Application Form |
The Regulatory Authority in New Zealand is Medsafe which is goverened by the Ministry of Health. Prior to conducting a clinical trial involving a non-licenced product, or a licenced product that is to be investigated via a new route or dose, an application must first be submitted to Medsafe. An application must also be made to SCOTT (Standing Committee on Therapeutic Trials).
Applications to Medsafe / SCOTT are the responsibility of the Sponsor but may be delegated to a New Zealand based representative.The current fee for an application to conduct a clinical trial is NZ$6,525. However, as this figure is subject to change please check the current fee schedule here.
More information about Medsafe can be found here.
More information about SCOTT can be found here.
Current guidelines for conduct of clinical research are defined in "New Zealand Regulatory Guidelines for Medicines. Volume 3: Interim Good Clinical Research Practice Guideline. August 1998." These guidelines are available in full on the Medsafe web-site.
