Australia is a great place to run clinical trials however at Australian Healthcare Solutions we understand this can present some geographical challenges. We have a long history of working with clients from the northern hemisphere and have the solutions to make running a clinical trial in Australia a smooth and successful venture for you.
Time and cost savings with our project management
The time and cost to travel to Australia on a regular basis can become onerous. At AHS we provide a solution for this. Proficient project management is pivotal to the service we deliver – this enables us to effectively become a local extension of your business in Australia and New Zealand. Provision of this local support results in time and cost savings for our clients, with less travel requirements to Australia.
Access to established clinical networks with leading physicians and research sites
We have long established clinical networks with leading physicians and research sites and expertise with local regulatory systems. At AHS we have over 20 years of experience working with medical device technologies across a broad clinical spectrum with specific expertise in Respiratory, Cardiology, Cardiothoracics and Interventional Radiology. These relationships and capabilities facilitate streamlined co-ordination and communication between all stakeholders, enabling us to deliver efficient ‘hands-on’ project management on your behalf.
Many medical device trials we undertake also require technical support for each case. Again this has cost and time implications for international clients if they are to provide case support from overseas. At AHS, our project managers are technical experts in their clinical field and specifically trained in your technology to provide first class technical case support. They become your ‘eyes and ears’ on the ground and are a valuable conduit between site and sponsor.
Reduced time to start up with effective regulatory applications
Australia boasts an efficient clinical trials approval system with the Clinical Trials Notification (CTN) scheme. Commercially sponsored trials are required to submit relevant materials directly to the human research ethics committee (HREC) at the institution of the proposed trial. Once the HREC?? institution at which the trial will be conducted gives final approval, the Therapeutic Goods Administration (TGA) is simply notified under the CTN scheme. No further approval process is required.
The CTN scheme has greatly reduced the regulatory burden on clinical trials sponsors through elimination of duplication. However to maximise reduced time to start up benefits of the CTN scheme, efficient HREC approval at the institution level is necessary. While there are standard materials required for all ethics approvals, every institution and state often has its own nuances with regard to documentation and processes.
Ensuring a tight ethics application first time around can save valuable time and money resulting in potentially faster approvals. Ultimately this results in an earlier commencement of your clinical trial. AHS is familiar with local HREC processes, documentation and the format required by specific institutions. AHS can assist with preparation of all required trial documentation and develop a tailored HREC submission dependent upon your requirements.