An emerging clinical research organisation in Australia and New Zealand
Meet the CRO specialising in medical devices
- Our Location
New South Wales, Australia
- Call Us
+61 481548166
Our approach
Our team will work seamlessly with your local and overseas stakeholders to develop and plan the most efficient strategic direction in light of market needs, study resources and your budget. We work with you to plan and optimise your readiness for each ethics and regulatory submission, delivering the optimal trial approach to obtain the desired outcome.
Time & Cost Effective
We provide a personalised approach with a service that is both time and cost-effective. Based in Sydney, our nimble team of research professionals has over 15 years’ experience managing clinical trials and helping companies bring their products to market in Australia and internationally.
Professional Team
We understand the issues faced by small and medium-sized organisations in this highly competitive and regulated space. As our client, you will appreciate the direct and personal involvement of our professional team at every step. This streamlines the process, facilitating a timely and economical outcome.
Why choose a specialist medical device CRO?
We provide adaptive clinical trial design to your technology to optimise your clinical investigation plan.
We offer an interim analysis to support informative decisions about your trial design and conduct.
We will advise you of an appropriate medical device classification according to the level of risk it may pose to users or patients, and make inquiries with the TGA (Therapeutic Goods Administration) on your behalf when needed.
We are familiar with methods to streamline the approval process and support your medical device registration on the ARTG (Australian Register of Therapeutic Goods). Devices must be registered in order to be lawfully supplied in Australia.
Our process for clinical device trials and approvals is scalable and adaptable to companies of all sizes.
conduct your trial in Australia
Why work with Us
Therapeutic expertise
Covering a wide range of clinical therapeutic areas such as gastroenterology, neuroscience, pain management, cardiovascular, orthopaedic, and more. We have a working knowledge of the competitive landscape including Key Opinion Leaders (KOLs) and their site subjective capabilities and past performance. We will share our knowledge of patient pathways and advocacy groups relevant to your medical device.
Regulatory know-how
Streamlined ethics and regulatory pathways in both private and public sectors. We understand implicitly the financial, operational and regulatory advantages of conducting clinical trials in Australia. We have relevant knowledge about the region and the clinical trial regulatory environment.
Medical writing
We tailor study design to optimise outcomes, costs and time
We customise the project's essential and supportive documents in clear and concise writing to accommodate any study needs.
Risk management and problem solving
Starting at the kick-off meeting and through the clinical trial, we work to identify a trial’s key risk points and provide creative solutions to keep the trial on track, helping you to reach your recruitment target.
Rapid clinical trial set-up
We provide practical solutions to overcome any obstacles gaining a seamless and smooth start to the clinical trial. Being familiar with the local regulations and authorities enables us to facilitate the trial according to predicted timelines.
Quality research and data management
We are committed to providing high-quality clinical trial management by partnering with our clients and sites and achieving accurate and reliable clinical data.
Government R&D tax incentive
Support in establishing a local entity and claim for government R&D tax incentive
Cost-effective services
We are a boutique and disruptive medical device CRO devoted to engaging with our partners in the quickest and most cost-effective way possible. We streamline the clinical trial set up and work closely with our stakeholders within time and budget constraints.
OUR MISSION
We are dedicated, creative and ambitious and we will work to find appropriate solutions to best achieve your trial goals.
As our name suggests, we are a visionary company and your trial success is our mission. Your trial matters to us. It is our honour to help bring therapeutic solutions supportive of patients’ needs.
We guarantee you will enjoy exceptional customer service experience when working in partnership with us.
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