STUDY START UP
Our staff have extensive experience in study start up activities and are committed to completing site initiation in the shortest possible timeframe to maximise the study recruitment period. We will ensure that the start up for your study is optimised, building in efficiencies and economies of scale at every opportunity, without compromising on quality.
Southern Star Research understands how crucial it is to have the appropriate CRA resource levels available at this critical period of the study. Our study teams are familiar with the local ethics committees and importantly will remain assigned to the study ensuring the valuable relationships developed with the site staff and investigators during the intensive start-up period are maintained throughout the lifecycle of the study.
As a condition of regulatory approval in Australia, the Therapeutic Goods Administration (TGA) requires a local entity to provide local study regulatory sponsorship for each clinical study. Southern Star Research can provide this service in many cases for overseas companies wishing to conduct trials in Australia but not wishing to establish an Australian entity. Southern Star Research can also arrange clinical trials insurance coverage to ensure local insurance requirements are met and facilitate the contracting process with sites.
It should be noted that to be eligible for the Australian Government R&D Tax Incentive, companies must have an Australian legal entity established.