Australia / Australasia: A Clinical Research Destination
Your first important milestone to raise your next round is medical evidence. Choosing WHERE to conduct your FIH, animal lab or pivotal trial can make all the difference.
Australia / Australasia: A Clinical Research Destination
Your first important milestone to raise your next round is medical evidence. Choosing WHERE to conduct your FIH, animal lab or pivotal trial can make all the difference.
Australia / Australasia: A Clinical Research Destination
Your first important milestone to raise your next round is medical evidence. Choosing WHERE to conduct your FIH, animal lab or pivotal trial can make all the difference.
Representative Patient Population
Access to diverse, treatment-experienced patients ideal for medical device trials.
High-Quality Sites & Investigators
World-class research facilities and experienced principal investigators.
Streamlined Approvals
Efficient regulatory pathways with faster approval timelines than many other regions.
Clear Regulatory Pathway
Well-defined processes through TGA with transparent requirements and guidelines.
Timeline and Costs
Competitive costs with R&D tax incentives and faster time-to-market compared to US and EU.
Representative Patient Population
Access to diverse, treatment-experienced patients ideal for medical device trials.
High-Quality Sites & Investigators
World-class research facilities and experienced principal investigators.
Streamlined Approvals
Efficient regulatory pathways with faster approval timelines than many other regions.
Clear Regulatory Pathway
Well-defined processes through TGA with transparent requirements and guidelines.
Timeline and Costs
Competitive costs with R&D tax incentives and faster time-to-market compared to US and EU.
Welcome Our Panel
Our Panel Discussion
Vanessa Gallois
Vanessa Gallois
Vanessa is the Senior Director Clinical Affairs from Highlife, a transcatheter mitral valve replacement technology.
Senior Director Clinical Affairs from Highlife, a transcatheter mitral valve replacement technology
Peter's career spans nearly every facet of this industry: from roles in strategics like Medtronic, to Global CROs including NAMSA, to the sponsor side across multiple technologies and even roles overseeing quality
Pedro Eerdmans
Youseff is a veteran entrepreneur and CEO currently leading Bariatech, a clinical stage company dedicated to treating obesity
Youseff Biadillah
Youseff is a veteran entrepreneur and CEO currently leading Bariatech, a clinical stage company dedicated to treating obesity
Joseph Panetta
Pedro's career spans nearly every facet of this industry: from roles in strategics like Medtronic, to Global CROs including NAMSA, to the sponsor side across multiple technologies and even roles overseeing quality.
Pedro Eerdmans
Youseff is a veteran entrepreneur and CEO currently leading Bariatech, a clinical stage company dedicated to treating obesity.
Youssef Biadillah
Ascend's Chief Marketing Officer will be moderating the discussion.
Joseph Panetta
Pedro Eerdmans
Pedro's career spans nearly every facet of this industry: from roles in strategics like Medtronic, to Global CROs including NAMSA, to the sponsor side across multiple technologies and even roles overseeing quality.
Youssef Biadillah
Youseff is a veteran entrepreneur and CEO currently leading Bariatech, a clinical stage company dedicated to treating obesity.
Joseph Panetta
Ascend's Chief Marketing Officer will be moderating the discussion.
The 5 P's of Med Tech Research
The 5 P's of Med Tech Research
The 5 P's of MedTech Research
The 5 P's of Med Tech Research
Process
Process
Process
In Australia, clinical research starts with:
Ethics Committee Review
Competent Authority Notification
The next steps are:
Governance
Labelling & Import
Monitoring.
Sponsors share their experience.
Pace
Pace
Pace
Franz Bozack of Sensome says:
“Asend’s timeline from inception to trial kick-off is un-matched.”
We understand time is money and work deliver on the “need for speed.”
Franz Bozack of Sensome says:
“Asend’s timeline from inception to trial kick-off is un-matched.”
We understand time is money and work deliver on the “need for speed.”
Sponsors share their experience.
Predictability
Predictability
Predictability
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.
Price
Price
Price
The local government incentivizes medical research via tax rebates. A US$300,000 can be fully executed in Australia for ~US$176,000.
Currency exchange rates favor both the USD and the EURO, meaning your money goes further.
Traditionally our budgets are within 5% of the final costs almost every single time. Why? Having done this so many times we are aware of all the hurdles, needs, and requirements necessary to deliver the desired data.
Moreover, we know the people, and that makes all the difference.
The local government incentivizes medical research via tax rebates. A US$300,000 can be fully executed in Australia for ~US$176,000.
Currency exchange rates favor both the USD and the EURO, meaning your money goes further.
Traditionally our budgets are within 5% of the final costs almost every single time. Why? Having done this so many times we are aware of all the hurdles, needs, and requirements necessary to deliver the desired data.
Moreover, we know the people, and that makes all the difference.
People
People
People
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.
(see case below)
Outside of your partner, your PIs and sites should be Top research institutions
with Highly Skilled investigators knowledgeable, experienced staff.
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.
Therapeutic Areas
Gastroenterology
Cardiovascular
Gyneocology
Orthopedics
Bariatrics
Endocrinology
Robotics
Gastroenterology
We optimize gastroenterology research by focusing on comprehensive patient engagement and precise data capture for improved gastrointestinal health solutions.
Tailored protocols addressing complex digestive tract disorders and comorbidities
Advanced monitoring tools for real-time tracking of patient-reported outcomes
Proven recruitment strategies targeting diverse populations and GI-specific indications
Therapeutic Areas
Gastroenterology
Cardiovascular
Gyneocology
Orthopedics
Bariatrics
Endocrinology
Robotics
Gastroenterology
We optimize gastroenterology research by focusing on comprehensive patient engagement and precise data capture for improved gastrointestinal health solutions.
Tailored protocols addressing complex digestive tract disorders and comorbidities
Advanced monitoring tools for real-time tracking of patient-reported outcomes
Proven recruitment strategies targeting diverse populations and GI-specific indications
Therapeutic Areas
Gastroenterology
Cardiovascular
Gyneocology
Orthopedics
Bariatrics
Endocrinology
Robotics
Gastroenterology
We optimize gastroenterology research by focusing on comprehensive patient engagement and precise data capture for improved gastrointestinal health solutions.
Tailored protocols addressing complex digestive tract disorders and comorbidities
Advanced monitoring tools for real-time tracking of patient-reported outcomes
Proven recruitment strategies targeting diverse populations and GI-specific indications
Therapeutic Areas
Gastroenterology
Cardiovascular
Gyneocology
Orthopedics
Bariatrics
Endocrinology
Robotics
Gastroenterology
We optimize gastroenterology research by focusing on comprehensive patient engagement and precise data capture for improved gastrointestinal health solutions.
Tailored protocols addressing complex digestive tract disorders and comorbidities
Advanced monitoring tools for real-time tracking of patient-reported outcomes
Proven recruitment strategies targeting diverse populations and GI-specific indications
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?
News & Insights from Med Tech Malta
News & Insights from Med Tech Malta
News & Insights from MedTech Malta 2025
Ready to Ascend?
Ready to experience a higher standard of clinical trial management?
Reach out today to learn how we can tailor our services to meet your unique research goals.
Our Address
Level 9, 123 Epping Rd, Macquarie Park NSW 2113 Australia
Phone Number
+61 2 88757898
Email Address
info@ascendcro.com
Ready to Ascend?
Ready to experience a higher standard of clinical trial management?
Reach out today to learn how we can tailor our services to meet your unique research goals.
Our Address
Level 9, 123 Epping Rd, Macquarie Park NSW 2113 Australia
Phone Number
+61 2 88757898
Email Address
info@ascendcro.com
Ready to Ascend?
Ready to experience a higher standard of clinical trial management?
Reach out today to learn how we can tailor our services to meet your unique research goals.
Our Address
Level 9, 123 Epping Rd, Macquarie Park NSW 2113 Australia
Phone Number
+61 2 88757898
Email Address
info@ascendcro.com
Ready to Ascend?
Ready to experience a higher standard of clinical trial management?
Reach out today to learn how we can tailor our services to meet your unique research goals.
Our Address
Level 9, 123 Epping Rd, Macquarie Park NSW 2113 Australia
Phone Number
+61 2 88757898
Email Address
info@ascendcro.com
info@ascendcro.com | +61 2 88757898
Copyright © 2025, Ascend Clinical. All Rights Reserved.
info@ascendcro.com
+61 2 88757898
Copyright © 2025, Ascend Clinical. All Rights Reserved.