The acquisition closed at the end of 2012 with Beltas contracts and all clinical staff transferring to CNS. Beltas will continue to provide GCP training in New Zealand.
“This acquisition continues our goal of widening our capabilities across Australia and New Zealand,” said Russell Neal, managing director of CNS. “By bringing together these two highly skilled clinical teams with years of collective experience we are able to offer our clients a truly regional solution.”
CNS also announced that its BioDesk service, launched a year ago, has seen success. BioDesk is a product development planning and regulatory affairs service designed for biotech companies wishing to enter the clinic faster by creating and managing a pre-clinical program that encompasses a globalized regulatory perspective while leveraging unique regional advantages.
“There is an obvious need for biotechnology companies to obtain expert support in making the transition from bench to the clinic, and BioDesk aims to provide this capability—particularly for companies looking to trial their products in Australia or New Zealand,” said Mark Reid, associate director, BioDesk and regulatory affairs.
CNS offers product development and regulatory affairs planning and development, clinical planning and study start-up, monitoring, project management, data management/biostatistics, medical consultancy/monitoring, medical writing, bioanalytical services and safety reporting.
CNS said its “Regional Advantage” is driven by the pragmatic regulatory environment in Australia and New Zealand that makes it possible for clients to enter the clinic quickly, without the need for prior approval from another regulatory agency
Additionally, the R&D tax credit in Australia refunds or “offsets” tax at 45% for small biotechs and 40% for large sponsors, a huge saving for companies conducting clinical trials in Australia. Certain transitional arrangements apply but, in general, the new provisions provide refundable or non-refundable tax offsets to encourage more companies to engage in R&D. The R&D tax incentive applies to expenditure incurred and the use of depreciating assets.
A 45% refundable tax offset, equivalent to a deduction of 150%, will be available to eligible small companies with an annual aggregate turnover of less than $20 million, provided they are not controlled by income tax exempt entities. These companies can receive a refundable tax offset of 45% of their R&D spending as part of the processing of their income tax return.
A 40% non-refundable tax offset will be available to companies with an annual aggregate turnover of $20 million or more—equivalent to a deduction of 133%. Unused offset amounts may be able to be carried forward for use in future income years.
The new tax incentive is available to corporations that are Australian residents, foreign corporations that are resident of a country with which Australia has a double tax agreement and carry on business through a permanent establishment in Australia, and to public trading trusts with a corporate trustee.
The Australian government also has announced that it will introduce quarterly credits for small and medium businesses beginning Jan. 1, 2014.