Established in 1994, our clinical trials testing arm based in Heidelberg Victoria, provides services to local and international pharmaceutical and biotechnology companies with capability in Australia, New Zealand and the Asia Pacific region (Hong Kong, India, Japan, Korea, Malaysia, Philippines, Singapore, Taiwan, Thailand, Vietnam). The Clinical Trials team is both innovative and experienced. Combined with the support of a state-of-the-art laboratory, our team has the ability to deliver customised, seamless and quality assured clinical trial solutions.
Our clinical trials unit maintains a comprehensive quality management system complemented by an external quality assurance program and extensive internal audit program ensuring ongoing compliance with Good Clinical Practice (GCP) and any other requirements for accreditation with respect to clinical trials - in particular 21 CFR Part 11.
Our Clinical Trials unit maintains:
- National Association of Testing Authorities (NATA) accreditation to ISO 15189:2007, incorporating Australian Standard AS/NZS 4308:2008 for urine drugs of abuse
- Level 1 certification to National Glycohemoglobin Standardization Program (NGSP)
Our trials unit, with a track record spanning over > 1000 trials, has:
- the quality focus required to meet the requisite regulatory requirements
- established partnerships with global affiliate laboratories and contract research organisations
- a dedicated secure clinical trials laboratory within a purpose built pathology laboratory situated in Heidelberg, Victoria
- the resources, experience, and innovative know-how to deliver customised, seamless and accurate clinical trial solutions
- a nationwide pathology network with access to accredited collection centres and the ability to offer specialised testing
- easy access to Melbourne’s International Airport and secure national and international courier networks