Diagnostics Trials

With the increasing emphasis on personalized medicine and targeted therapies, diagnostics (as well as biomarkers) have an important role in drug development and healthcare delivery. In becoming more crucial to pharmaceutical development, both small and large companies are showing growing interest in diagnostics, and for diagnostics that specifically complement therapeutics, ie theranostics.

BELTAS has managed trial sites across New Zealand and Australia, for diagnostic development, in particular for cancer detection and management. The company offers full-service from initial consultancy, study set-up, clinical trial management, ethics (IRB) and regulatory submissions, site monitoring, through to site close out and database lock.

Diagnostics are faster to develop due to their lower risk, simpler regulatory procedures, and fewer trial phases. This makes them cost-effective to trial, and attractive to development companies and funders.

Investigators generally recruit well to diagnostic trials, as they are relatively straightforward to run, and can improve patient outcomes through both early detection (particularly important in oncology and infectious diseases) and the ability to identify patients who are likely to respond to an associated therapeutic.

"Contract research organizations (CROs) provide substantial global capacity to drug developers and have become a critical contributor to clinical trial activity"

- Tufts CSDD