Novotech checklist for CRO partnering and trials selection is Australia & Asia
June 21, 2006 by admin
Filed under Company News, Company News 2006
June 21, 2006 – Philadelphia, PA —Size match – ensure the CRO is a good match in organizational size and reach. Make sure the CRO has experience working with companies at a similar stage and growth phase, eg, small to medium sized biotechs often find it frustrating working with the large global CROs as they can struggle with response times and “client value/priority” issues.
Site audit – physically view the corporate headquarters and associated facilities/sites to ensure they are at the standards required and offer the features promised by the CRO
Technology – ensure data collection and reporting compatibility with FDA requirements and sponsor firm
Patient recruitment record – the speed and quality of patient recruitment need to be clearly demonstrated.
Demonstrated experience in the disease/condition
Demonstrated experience in the trial Phase required by the sponsor
International trials experience – track record
Local knowledge – unparalleled knowledge of local regulatory procedures
Cost savings – once all the above have been reviewed only then apply cost saving matrix. If any of the above are not in place, any perceived up-front savings will quickly be eroded.
Referral – preferably the CRO would be referred to the sponsor by a trusted source and or industry analysts/reports.
About Novotech
Headquartered in Sydney, Novotech is focused on the Australian and New Zealand markets but has worldwide reach through the company’s subsidiary in the United Kingdom and its US operations.
As the largest independent CRO in Australia, Novotech offers a level of flexibility and local knowledge that is unmatched among other contract research organizations in the region.
Novotech’s US operations make it uniquely positioned to offer trials across the two countries, providing the benefits of Australia’s highly regarded cost-effective clinical trial capabilities, and at
the same time take advantage of access to the much larger US market for rapid patient enrolment – a service that has to date only been available via large global CROs at higher overhead costs.
The Australian Clinical Trials Advantage
Increasingly, US companies are turning to Australia to expedite the pace, and reduce the cost, of clinical trials, while maintaining the high standard of research that US authorities demand. Australia has been ranked the number one location to conduct pharmaceutical clinical trials in an international benchmarking study undertaken by the Economist Intelligence Unit (EIU). The EIU study ranked Australia against six countries – US, UK, Germany, Japan, Singapore and India. Other studies have found that clinical research costs may be as much as 30 percent lower in Australia than in the United States and Europe. In addition, Australian regulatory procedures often enable a trial to begin in as little as 2-3 months from the initiation of the approval process. This compares favorably to usual timelines in major Western countries.
