Australian Healthcare Solutions has extensive experience in running medical device trials in Australia and New Zealand for both domestic and international clients.
Our experience, our expertise and our approach have seen high levels of client satisfaction – in fact much of our new trial work is referred by past or existing clients.
Why choose Australian Healthcare Solutions as your CRO? We have asked our clients and we believe a number key attributes distinguish our Clinical Trial Services:
- Our Vision, Our People, Our Relationships
- We understand the challenges for international clients
- We understand the local Australian regulatory systems
- Specialised experience in Respiratory, Cardiology, Cardiothoracic and Interventional Radiology
- We provide expert technical trial support and project management
- We are a niche medical device CRO
Our Vision, Our People, Our Relationships
At Australian Healthcare Solutions, we are passionate about assisting companies with their vision of delivering medical technology that improves lives.
Our people are at the heart of our service delivery. We employ professionals who share the AHS vision, are experts in their fields and are dedicated to working with our clients to achieve their goals.
At AHS great relationships with site and sponsor are key to how we operate and achieve success.
When you partner with AHS for your clinical trial services, that is exactly what we become – your partner. Being a niche organisation we ensure we work with you to intimately understand your technology and business goals so that everything we do becomes an extension of your business.
We highly value our relationships with clinical trial sites and physicians. It is the depth of these partnerships that enable us to smoothly facilitate collaboration between site and sponsor.
We understand the challenges for international clients
Australia is a great place to run clinical trials however at Australian Healthcare Solutions we understand this can present some geographical challenges. 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 and expert technical support 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.
We have long established clinical networks with leading physicians and research sites and expertise with local regulatory systems. 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.
We understand the local Australian regulatory systems
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 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 has its own nuances with regard to documentation and processes.
Ensuring a tight ethics application first time round can save valuable time and money with faster approval. 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.
Specialised experience in Respiratory, Cardiology, Cardiothoracic and Interventional Radiology
At AHS we have over 20 years of experience working with medical device technologies across a broad clinical spectrum.
We have specific clinical expertise and networks in Respiratory, Cardiology, Cardiothoracic and Interventional Radiology. We have a deep clinical knowledge in these specialities and have undertaken many medical device trials in these areas.
With years of experience working in these clinical areas, we have longstanding relationships physicians and access to key opinion leaders. We have established networks with clinical trial sites and good working relationships with their personnel. Our familiarity with local Ethics and Governance pathways also means we can efficiently navigate the nuances that are particular to each hospital/state.
When you partner with AHS for your clinical trial you have immediate access to our local networks and expertise.
We provide expert technical trial support and project management
At Australian Healthcare Solutions we pride ourselves on the quality of our project management and technical support – it is pivotal to the service we provide.
Having local knowledge and established relationships and networks enables streamlined navigation of trial logistics and effective communication. Our project managers become a valuable conduit between site and sponsor.
Our project managers are all clinical experts in their fields. Your project manager will have an extensive clinical background relevant to your technology and they will have respected relationships with physicians in their clinical fields.
If your technology requires, case support AHS can provide this for you. As with our project managers, our technical support people are experienced professionals who are technical experts in their fields. They will be specifically trained in your technology to provide first class technical support.
Provision of local technical case support has been highly valued by our clients, particularly our international clients. Local support has eliminated the need to fly staff out to Australia for each case resulting in significant cost and time savings.
We are a niche medical device CRO
Being a niche organisation means we are experts our clinical areas, our relationships are deep and we are intimate with the medical device clinical trial landscape. We have the flexibility to tailor our services to meet your organisation’s specific needs.