Clinical Trial Management Consulting Services In Australia - CRO
Australia has a very sophisticated healthcare system and many world leading 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 Asia Pacific Pty Ltd in conjunction with its Australian associate Sci2Rx Pty Ltd helps medical device manufacturers assess the suitability of Australia as a site for conducting clinical trials for their product and assists in researching and analyzing the appropriate clinicians and Institutions and in screening CRO 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 to ensure ongoing success of the trials. Typically, we perform the following services for our medical device and IVD clients:
1. Assessment of appropriate clinicians, Institutions and CRO
- Evaluate track record of clinicians, Institutions in relation to the type of devices to be trialed
- 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. CRO qualification and selection
- Thorough pre-qualification of CROs based on needs
- Intensive screening of CROs 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
- Acting as the liaison between your company and your appointed CRO
- Providing assistance with troubleshooting
- Regularly contacting and visiting your CRO to assess progress
- Provide the manufacturer with independent reports on patient recruitment and trial progress and issues arising
- Represent the manufacturer in any liaison activities with clinicians or Institutions as required
Let us help assist you with clinical trial management in Australia. Contact us today for more information.
