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Australia
- High quality medical research: both preclinical and clinical
- Politically stable, safe and robust legal and regulatory system
- Sophisticated “Western” medical environment
- Quick start-up time of clinical trials aids access to US & EU
- Preferred for incorporation in multi-national trials
Queensland
- Strong Government commitment and investment
- State-of-the-art medical research facilities and hospitals
- Strengths in pre-clinical and early clinical development phases
- Favourite destination for biotechnology start-ups
QCTN
- Is a network of “best-of-breed” preclinical and clinical service providers
- Serves as one-stop-shop for accessing service providers
- Provides in-depth Scientific, Ethics and Biosafety review services
- Is establishing very strong and influential international network
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Fast start - for most trials no need for an approval process (i.e. via the CTN process)
Rigorous review of gene therapy and related therapy studies by Australian authorities
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Use Australia for early phase clinical trials as a stepping stone for starting trials in US/EU
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| Highly skilled clinical staff (ICH-GCP) Very modern facilities Strong IP protection |
Use Australia as part of Multinational clinical trials for US or EU markets |
| ICH-GCP mandatory for all trials |
Necessary to arrange local (=Australian) legal representation (“sponsorship”) and insurance |
| Cost-effective as compared to US, EU, JPN |
Consider doing Bridging trials in Australia for Asian markets |
| High % on-time completion of trials and there is capacity to do more trials |
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| Multicultural population = 21 million, mainly Caucasian and Asian |
Possibility of continuing seasonal studies in Australia during off-season in the Northern Hemisphere |
| Excellent network of preclinical, genomic & bioinformatics and early phase clinical trials service providers in Queensland |
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| Ready access to Comparator drugs, Background therapy, Standards of care, Disease tracking programs for notifiable disease outbreaks and Flu monitoring network |
Medical-technical documentation such as Case Report Forms, Informed Consent Forms, etc. are in English |
Australia
- High quality medical research: both preclinical and clinical
- Politically stable, safe and robust legal and regulatory system
- Sophisticated “Western” medical environment
- Quick start-up time of clinical trials aids access to US & EU
- Preferred for incorporation in multi-national trials
Queensland
- Strong Government commitment and investment
- State-of-the-art medical research facilities and hospitals
- Strengths in pre-clinical and early clinical development phases
- Favourite destination for biotechnology start-ups
QCTN
- Is a network of “best-of-breed” preclinical and clinical service providers
- Serves as one-stop-shop for accessing service providers
- Provides in-depth Scientific, Ethics and Biosafety review services
- Is establishing very strong and influential international network
|
Fast start - for most trials no need for an approval process (i.e. via the CTN process)
Rigorous review of gene therapy and related therapy studies by Australian authorities
|
Use Australia for early phase clinical trials as a stepping stone for starting trials in US/EU
|
| Highly skilled clinical staff (ICH-GCP) Very modern facilities Strong IP protection |
Use Australia as part of Multinational clinical trials for US or EU markets |
| ICH-GCP mandatory for all trials |
Necessary to arrange local (=Australian) legal representation (“sponsorship”) and insurance |
| Cost-effective as compared to US, EU, JPN |
Consider doing Bridging trials in Australia for Asian markets |
| High % on-time completion of trials and there is capacity to do more trials |
|
| Multicultural population = 21 million, mainly Caucasian and Asian |
Possibility of continuing seasonal studies in Australia during off-season in the Northern Hemisphere |
| Excellent network of preclinical, genomic & bioinformatics and early phase clinical trials service providers in Queensland |
|
| Ready access to Comparator drugs, Background therapy, Standards of care, Disease tracking programs for notifiable disease outbreaks and Flu monitoring network |
Medical-technical documentation such as Case Report Forms, Informed Consent Forms, etc. are in English |
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