Australia is a great place to run clinical trials however at Australian Healthcare Solutions we recognise this can present some geographical challenges. We have a long history of working with clients from the northern hemisphere, particularly the USA, and have the solutions to make running a clinical trial in Australia a smooth, cost effective 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 – especially for an early stage medical device company. At AHS we provide a solution for this. Expert 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 project 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 as well as expertise in navigating 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, Cardiac Surgery, Vascular, Thoracis and Interventional Radiology. These relationships and capabilities facilitate streamlined co-ordination and communication between all stakeholders, enabling us to deliver proficiant ‘hands-on’ project management on your behalf.
Field Clinical Support
Many medical device trials we undertake also require field clinical case support. Again this has cost and time implications for international clients if they are to provide field clinical support from overseas. At AHS, our Field Clinical Support professionals are technical experts in their clinical field and specifically trained in your technology to provide first class clinical 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 via a Competent Authority is required.
The Australian CTN scheme has greatly reduced the regulatory burden on clinical trials sponsors through elimination of duplication of processes. However to maximise the benefits the CTN scheme offers with respect to reduced time to start up, efficient HREC submission and approval at the institution level is necessary. While there are standard materials required for all ethics approvals, institutions and states often have nuances with regard to required documentation and processes.
Ensuring a comprehensive 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.
Budgeting for your trial – cost savings
Negotiating site budgets can often make or break the financial success of your trial. AHS has an in-depth knowledge of the costs of tests and procedures that are frequently utilised in medical device trials in Australia and New Zealand With our local knowledge and experience we can assist you develop a sponsor budget that can be presented to sites as a starting point for budget negotiations and avoid paying above what is required on a per patient basis.