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Australia/New Zealand
Preparation of applications to IECs/IRBs is a specialised regulatory task. At Novotech, we have senior regulatory specialists dedicated to managing the ethics approval process. As Australia does not have a national IRB structure, each site involved in a study specifically requires clearance by its own institutional ethics committee. For large multicentre studies, efficient completion of this step can make the difference between meeting study projected timelines or being out by months.
Our prior experience in this area covers nearly all major institutions in the country, as well as the SCOTT process in New Zealand. As one of the few CROs in Australia with a dedicated ethics clearance service, we can take on individual projects where our brief may be confined just to managing the ethics process, with the client taking responsibility for its own project management and monitoring tasks.
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