Researchers conducting clinical studies in New Zealand must consider the protocol and/or design of studies, resource issues, ethical audit, regulatory oversight, institutional strategies, research policy and many other topics. Academic and public universities have a research or other office. Research offices facilitate close working relationships between researchers, clinicians, ethics committees, promotion organizations and commercial sponsors. These offices play a central role in approving research activities and ensure that DHB and/or local institutions that govern policies and procedures are followed. The New Zealand Association of Clinical Research (NZACRes) has developed a standardized clinical research agreement (SCTRA) based on the Medicines Australia model that has been used successfully in Australia. More recently, NZACRes has consulted extensively with the New Zealand clinical research industry to update the standardized clinical trial research agreement. The computational tool is an Excel table model that can be used by websites to facilitate accurate test calculation and to support transparent pricing discussions. New Zealand has a first-rate track record with early-stage studies and concept demonstration validated by independent, clean and accurate clinical data. It is not a mandatory instrument; it is designed as a useful tool that streamlines site budgeting processes and provides a common financial „language“ for calculating clinical trial costs. In addition, the calculation tool is not expected to replace budget discussions and negotiations on the sponsors` website. It is only an internal document that allows websites to see where their costs lie. As of January 1, 2011, all clinical studies conducted in New Zealand should be conducted in accordance with the Good Clinical Practice Guide (CPMP/ICH/135/95). This applies regardless of whether or not the study requires marketing authorization under the Drug Act.

In some cases, the requirements of the CPMP/ICH/ICH/135/95 cover certain provisions of the 1981 Medicines Act or other relevant New Zealand legislation (e.g.B. Reporting or Record Retention Legislation) in particular to the provisions of the Medicines Act 1981 or any other New Zealand legislation in this area (e.g. (b) legislation on reporting obligations or the retention of records). It is therefore necessary to amend some of the requirements of CPMP/ICH/135/95 in order to comply with New Zealand legislation. As a leading clinical trials provider, we pride ourselves on providing accurate, fast and independent clinical data in a safe and high quality environment.