NSW Health / Early Phase Clinical Trials Market Sounding - HI22547

NSW Health is requesting information from industry to inform potential future investment decisions and procurement strategies for Early Phase Clinical Trials infrastructure. Respondents with interest in investing, partnering operating and supporting new or expanded Early Phase Clinical Trials infrastructure are encouraged to respond. Any infrastructure solution will be developed with the aim of being globally competitive and financially sustainable, conducting all types of Phase I trials (including Ib and any other variant), enrolling either healthy volunteers, volunteer patients and/or patients, including First In Human (FIH). The location of any new infrastructure will need to consider accessibility to a diverse pool of potential participants and stakeholders, will requires access to laboratory, pharmaceutical and academic services, as well as full clinical and emergency care. It will be compliant with the Early Phase Trial Quality Recognition Scheme (QRS) and outlined requirements. With capacity to serve metropolitan, rural, regional and remote communities, clinical trials undertaken in NSW will meet Regulatory submission requirements which require diverse participants, across cultural, linguistic, age (including paediatric), sex and gender, and location demographics, to promote equity of trials. Any new facility will be staffed by a world-class workforce, with appropriate training to deliver patient-centred care for both clinical trials and standard of care and will be certified according to quality criteria for conduct of high-risk trials. These trials will be reviewed and approved by a specialist Human Research Ethics Committee (HREC) under the NSW Health Early Phase Clinical Trial Framework. The vision is for NSW to become the destination of choice for early phase trials, with the Facility being an integral contribution. Advances in medicine and ongoing demand for early phase clinical trials in NSW is driving the need to critically assess available early phase trial capacity and infrastructure. Increasing interest is being expressed by the sector for an expansion of the state’s Early Phase Clinical Trial Infrastructure. This market sounding will investigate the feasibility for the establishing a sustainable facility to increase dedicated early phase capacity in NSW.

The virtual Market Sounding Briefing will be held at 4pm on the 16 November 2022. Registration to attend is required, please email HI-Commercial@health.nsw.gov.au to receive log in details for the briefing.

HI draws to your attention the obligations in relation to the Implementation Guidelines to the New South Wales Code of Practice for Procurement: Building and Construction Industry (the Guidelines), applicable to projects of $10 million and above.

The Guidelines can be downloaded from www.industrialrelations.nsw.gov.au (follow the links to Construction).