ARCS Australia has submitted its 2026–27 Federal Pre-Budget Submission, calling on Government to ensure that investment in Australia’s clinical trials system is matched by targeted and sustained investment in workforce capability.

The submission, Building a Globally Competitive Clinical Trials System: Infrastructure and Workforce Must Advance Together, outlines the risk of pursuing regulatory and digital reform without the skilled workforce required to deliver clinical trials at scale.

“Australia has made important progress in strengthening its clinical trials environment, particularly through the National One Stop Shop,” said Dr Tim Boyle, CEO of ARCS Australia. “But platforms and policy alone do not run clinical trials. People do.”

Two priorities that must advance together

The ARCS submission focuses on two inseparable priorities: ongoing funding for the National One Stop Shop (NOSS) and investment in clinical trials workforce capability.

ARCS strongly supports NOSS as a once-in-a-generation reform designed to streamline approvals, reduce duplication across jurisdictions and improve Australia’s global competitiveness. However, the submission emphasises that continued Commonwealth funding will be essential to ensure NOSS moves from early development to full national implementation.

“NOSS has enormous potential to improve speed, coordination and transparency,” Dr Boyle said. “But without sustained funding, there is a real risk that momentum stalls before the platform is fully delivered and adopted nationally.”

Workforce capacity is now a delivery risk

While regulatory reform is critical, ARCS argues that workforce constraints are now one of the most significant risks to Australia’s clinical trials ambitions.

Drawing on findings from the Strengthening Australia’s Clinical Trials Workforce White Paper, the submission highlights persistent workforce shortages, high turnover, unclear career pathways, fragmented training and the absence of nationally consistent competency and accreditation frameworks.

“We are already seeing sponsors cite workforce capacity as a constraint on placing trials in Australia,” Dr Boyle said. “Sites want to run trials, investigators are engaged, but without enough trained coordinators, CRAs and research staff, approvals alone don’t translate into delivered studies.”

The submission warns that faster approvals, if not matched with workforce investment, risk simply shifting bottlenecks downstream to trial sites.

Workforce capability as national infrastructure

ARCS is calling for workforce capability to be treated as core national research infrastructure, rather than an adjunct to regulatory reform.

“There is little value in Government investment in NOSS and international trials attraction if Australia doesn’t have the workforce capacity to deliver the trials that follow,” Dr Boyle said. “Workforce capability is not a ‘nice to have’. It is fundamental to productivity, quality and Australia’s reputation as a trials destination.”

To address this, ARCS has proposed Commonwealth investment in a National Clinical Trials Workforce Capability Program, aligned to the recommendations of its workforce white paper. This includes nationally recognised competency pathways, coordinated education and entry routes, structured graduate and internship programs, and measures to improve retention and sustainability across the sector.

A clear opportunity for Government

From a fiscal and policy perspective, the submission positions workforce investment as a low-risk, high-return lever to maximise the impact of existing Government expenditure on clinical trials reform.

“If we want NOSS to deliver real economic and health returns, we need to invest in the people who make the system work,” Dr Boyle said. “Aligning infrastructure and workforce investment is how Australia secures long-term competitiveness in clinical research.”

ARCS has reaffirmed its readiness to work in partnership with Government to deliver nationally consistent workforce solutions, building on its established role in education, competency frameworks and professional standards.

The submission references the Strengthening Australia’s Clinical Trials Workforce White Paper, which is available on the ARCS website:
https://www.arcs.com.au/news-item/21396/strengthening-australias-clinical-trials-workforce-white-paper