Services

ZenTech is an independant CRO (Contract Research Organisation) that can provide a full range of services including study design and protocol writing, ethics committee submission, assay development and sample analysis, trial co-ordination, management of the study and final reporting. These services include:

  • Bioequivalence studies, clinical, efficacy and feasibility studies and safety studies
  • Clinical Trial Co-ordination, monitoring and management
  • Laboratory services (including dissolution and stability testing, content and comparative bench chemistry)
  • Data Management and Biostatistical Analysis

ZenTech has conducted studies for submission in both the local (New Zealand and Australia) and international markets.

ZenTech continues to review and improve the quality of procedures used during sample collection, sample analysis, data analysis, documentation and reporting to achieve the standard required by Medsafe, TGA, EU and FDA regulatory authorities.

In addition to preforming single dose and multiple dose bioequivalence studies, ZenTech is also capable of preforming clinical and safety studies and has preformed a number of these according to GCP standards.

Furthermore, ZenTech can provide statistical consulting services to other organisations. This includes developing experimental designs and survey sampling plans, and also performing statistical analyses using SAS, Splus and R.

The Zenith Biomedical Ethics Committee which has gained and continues to maintain accreditation from the Health Research Council of New Zealand.


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