Australian Healthcare Solutions is a niche medical device Contract Research Organisation (CRO) based in Australia. We offer the full spectrum of CRO as well as Field Clinical Support services required to seamlessly run your medical device clinical trial in Australia and New Zealand geographies.
Our CRO services
Our CRO and Field Clinical Support service offering is flexible. We can partner with you to fully manage your clinical trial from beginning to end or we can customise a suite of services to meet your specific trial needs:
- Project management
- Key Opinion Leader (KOL) and site identification
- Preparation of full Ethics (HREC) submissions and amendments
- Management regulatory requirements (TGA – CTN)
- Site initiation and training
- Trial master file development and management
- Development of patient and site binders
- Development of CRFs
- Field clinical support
- Sponsorship facilitation
- Management of adverse events / reporting
- Subject recruitment
- Study close out
Medical device specialists
Australian Healthcare Solutions (AHS) specialises in running medical device trials. We work with medical device companies at any stage of their commercial journey. We are equipped to run small, single-site, first-in-human trials through to multi-centre trials within Australia and New Zealand. Similarly we are positioned to run the Australian arm of multi-national trials.
We work with device technologies across a broad clinical spectrum with specific clinical expertise and relationships in Respiratory, Cardiology, Cardiac Surgery, Vascular, Thoracics and Interventional Radiology spheres.
Quality and efficiency
At AHS delivering quality is our priority. Our clinical trial services are all built on and delivered according to Good Clinical Practice (GCP) principles and standards. Our team of Project Managers, Monitors and Field Clinical Support staff all practice according to International GCP standard (ISO-14155). They are experts in their fields with clinical experience matched to your technology.
At AHS we know that getting a technology to trial start up and ultimately to market as quickly as possible is a key goal for any early stage company. At AHS our understanding of the device trial landscape and local HREC requirements in Australia and New Zealand, coupled with the strength and depth of our relationships with physicians and trial sites, enable us to efficiently navigate and manage trial processes.