Australia has a very sophisticated healthcare system and many world class clinicians who are keen to trial new medical device technologies. Conducting clinical trials in Australia is cost effective, and the data generated is well regarded internationally.
Emergo can help medical device manufacturers assess the suitability of Australia as a site for conducting clinical trials for their product. We can also assist in researching and analyzing the appropriate clinicians and institutions and in screening CROs as prospective clinical trial managers in Australia and New Zealand.
We take a multi-faceted approach to clinical trial management. The goal is to make sure that the clinicians, institutions and potential CRO partners are objectively evaluated based on your requirements, and carefully monitored afterwards for ongoing success of the trials. We perform the following services for our medical device and IVD clients:
1. Assessment of appropriate clinicians, institutions and CROs
- Evaluate track record of clinicians and institutions for the type of devices to be investigated.
- Assist in creating awareness of manufacturer's product with key clinicians and facilitate relationship between clinicians and manufacturer.
- Regulatory and product compliance requirements.
- Research IRB and Trial Indemnity requirements.
2. Australia CRO qualification and selection
- Thorough pre-qualification of Australian CRO based on needs.
- Intensive screening of CRO and level of experience, service level, etc. based on manufacturer's criteria.
- Intensive one-on-one interviews to determine a "short list" of qualified candidates.
- Final selection by you based on your comfort level and objectives.
3. Clinical trial management in Australia
- Liaison between your company and your appointed CRO in Australia.
- Assistance with troubleshooting.
- Contact and visit your Australian CRO to assess progress.
- Provide the manufacturer with independent reports on patient recruitment, trial progress and issues.
- Represent the manufacturer in any liaison activities with clinicians or institutions as required.
Please contact us for more information on Australia clinical trial and CRO management consulting.