Ensuring therapeutic outcomes

Healthtech entrepreneurs are driven by a vision to improve the health of others. Substantiating therapeutic claims with credible and comprehensive scientific data is a major focus for innovators in this field.

Clinical validation, through the likes of clinical studies and trials, needs to be undertaken to do this, and in a way that also meets the requirements of regulators and customers (such as healthcare providers).

Clinical trials in New Zealand

You can learn more about conducting clinical trials on the Clinical Trials in New Zealand website.

For an overview of the general steps involved in the first in-human clinical trials of a pharmaceutical or the clinical investigation steps for a medical device, you can download example process diagrams below.

Download the clinical validation process diagrams

The clinical validation process is explored in greater detail in the fictional example case studies included in the following section.

A scientist working with samples in a lab.

Case studies

To illustrate some clinical validation 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).

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.

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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.

Download PDF

Clinical trials in Australia

Find out more about undertaking clinical trials in Australia.

A scientist working with samples in a test tube.

Find out more

Clinical validation is a crucial part of the healthtech innovation journey. Undertaking clinical studies or trials is complex and highly regulated; in addition, the clinical validation landscape is constantly evolving. To support healthtech innovators and businesses – of all types and stages – stay up to date with what’s happening in this area, we’ve rounded up the following series of reports, articles and resources.

Latest Resources

Browse more resources on our Articles & Reports page:

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