Updated checklist for CRO partnering and trials selection in Australasian region announced at BIO 2007

May 8, 2007 – Boston, MA — Novotech, the largest Australian owned contract research organization (CRO) with offices on the US east and west coasts, has released its updated “Clinical Trials Checklist” for CROs, biotech, pharma and even VCs, to assist in the often challenging task of selecting a clinical trials partner in the Australasian region for global studies.

Novotech is the recipient of the Frost & Sullivan Asian CRO of the Year 2006 – Australia Award and a winner of the Deloitte Fast 500 Asia Pacific 2006 program.

Novotech CEO Alek Safarian said there were some considerable variations in opportunities and delivery in the Australian and Asian region for drug trials and research, and the updated checklist would help guide sponsors to weigh up their options to suit their needs.

Issues such as regulatory environment, clinical data management, approval timelines, cost saving opportunities, IP protection, reliable data issues, regional disparities, and availability of experienced staff, are all part of the decision making mix.

Safarian said one of the best indications that a CRO has the necessary experience in their market is that they also offer regulatory consulting services. However, he said “Still the most important decider, once a fit is established, is a site audit of the corporate headquarters and associated facilities to ensure they are at the standards required.”

Speed and cost savings are not enough on their own, he said. “Decision-makers really need to see for themselves that the CRO is offering exactly what they are promising to ensure quality and smooth operational progress.”

He said Novotech regularly hosts client audits of its Sydney, Melbourne, and Brisbane facilities prior to commencing trials with US firms. Novotech has worked with more than 50 U.S.-based and European pharmaceutical and biotech companies over the past 3 years.

He said a CRO also needs to demonstrate international expertise, a track record of trials with US and other pharma and biotech firms, have unparalleled knowledge of local regulatory procedures, and expertise in the requirements of international regulatory authorities. Ideally they are also referrals from other trusted sources.

According to Frost & Sullivan Program Manager Shruti Dwivedi, Novotech demonstrated “exemplary growth and performance” and is well placed to benefit from the 15% per annum increase in trials conducted in Australia, much of which is coming from large pharmaceutical firms.

Novotech came out on top against its competitors after being evaluated on key criteria including “research capabilities, breadth and depth of services, geographical coverage, and alliances/partnerships that would enhance capabilities and the growth strategies adopted in pursuit of corporate objectives”, said Dwivedi.

“Novotech offers a broad spectrum of services in Australia and New Zealand, catered by a strong research team, experienced in diverse therapeutic fields. It has formed a subsidiary in UK as well as external partnerships/alliances in North America and other regions to widen its geographical reach.”

Novotech also won praise for its therapeutic experience with its special focus on Oncology, Ophthalmology and Cardiology trials. It conducts approximately 40 clinical trials every year, where nearly 80% are in Phase II & III, with remaining in Phase 1.

For meetings with Novotech at BIO 2007 please contact: Alek Safarian at 760-931-4841.

For a copy of the new CRO Checklist please contact Susan Fitzpatrick 650 279 7771 susan@datelinemedia.com

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

www.novotech-cro.com

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.