Phase II, III and IV clinical trials

BELTAS monitors Phase II, Phase III and Phase IV trials in New Zealand, Australia and Europe.

Phase II trials are done at one or just a few sites. The population in New Zealand and Australia is 25 million concentrated in a few main centres; therefore Phase II studies, not requiring a large number of patients and requiring directly involved investigators, are often suited to the region.

In Phase III clinical studies, Australian & New Zealand sites make a strong contribution to international collaborations and are recognised globally for their recruitment and retention rates in most therapeutic areas.

BELTAS manages OUS (Outside US) studies for US clients across its areas of operations - balancing target markets (e.g. companies wishing to gain a CE mark for devices) with cost-effective sites to provide sufficient and timely study data.

Phase IV studies tend to be of more interest in Europe, but some work is also done in this area in New Zealand and Australia, depending on the therapeutic area and local needs. BELTAS can assist with the local registration of products and sourcing a distributor, for clinical trial clients.

Advantages of conducting Phase II – IV research in New Zealand & Australia include:

• Fewer competing studies
• English language environment
• Access to key opinion leaders and investigators
• Excellent clinical recruitment and retention rates in many areas
• Higher percentage of treatment naïve patients in some areas e.g. oncology
• Responsiveness to changes in requirements as projects develop (adaptive trials)
• Good infrastructure for clinical trial processes & technology
• Lower costs and lower overheads
• Quality data to ICH-GCP and FDA standards

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

- Tufts CSDD