In Australia, clinical research starts with:
Ethics Committee Review
Competent Authority Notification
The next steps are:
Governance
Labelling & Import
Monitoring.
Sponsors share their experience.
Australia’s regulatory authority, the TGA, presents a streamlined, well-defined process for medical research. This includes:
Harmonized with GCP requirements
Adopting ISO standards means data is favorably viewed by the FDA
This clearly defined process delivers a predictable timeline and cost structure for your trial.
Meaning the CRO you select, as well as your
expanded on-the-ground team.
Your CRO partner should be veterans at all clinical touchpoints and deliver the kinds of deep intel you had not even thought of.
Outside of your partner, your PIs and sites should be Top research institutions
with Highly Skilled investigators knowledgeable, experienced staff.
Understanding FDA Pathways:
What the Data Really Shows
Whether seeking a 510(k), Denovo or PMA, how much can you rely on the FDA website to shape your expectations around time and costs? Physician, former FDA rep and NAMSA Strategy Consultant Adam Saltman performed a 'meta analysis' of the last 300 FDA approvals in these categories to gauge the reality:
*First time submission can get a 'pass' and submit for free
The delta between the FDA website and reality is due to:
The FDA likes to change the rules – no surprise there!
There are always holds, questions, deferrals, meetings and more information is desired and required
Worth Considering
Sites in certain countries allow non-resident physicians to perform procedures. This is not allowed in Australia, but:
A World-Class animal lab is at your disposal for training
Cadaver labs are also offered for demonstrations
Remote viewing for procedures is routine
Your team is allowed in the room during the procedure (as observers)
Ideally, your device will ultimately be used by physicians across the world. Shouldn't you know how easy it is to train them on the device and procedure?
