As regulatory uncertainty grows in the United States, US biotechs are increasingly looking to Australia as a stable and predictable launchpad for early-phase clinical trials. With its globally accepted regulatory framework, accelerated timelines, and 43.5% R&D rebate, Australia offers a compelling advantage — and Avance Clinical, Australia’s leading early-phase specialist CRO, is delivering the GlobalReady solution to help biotechs de-risk, conserve capital and accelerate their programs.

“In today’s capital-constrained biotech environment, sponsors need solutions that deliver speed, predictability, quality, and capital efficiency,” said Ben Edwards, Chief Operating Officer at Avance Clinical. “Australia is a smart strategic choice — it allows biotechs to start faster, control costs, reduce burn rate, and generate FDA-accepted data without the delays and complexity of the US IND process in a Phase I setting.”

Through its GlobalReady program, Avance Clinical enables biotech sponsors to rapidly initiate early phase trials in Australia — often within 5 to 6 weeks — without the need for an open IND. The company’s deep regulatory and scientific expertise ensures that data generated under the Australian Therapeutic Goods Administration (TGA) framework is accepted by the FDA and other major regulatory agencies worldwide.

In addition to regulatory speed and data quality, Australia offers a unique fiscal advantage with its 43.5% R&D tax rebate, significantly reducing early clinical trial costs — a major incentive for venture-backed biotech companies managing limited runway.

As part of its GlobalReady model, Avance Clinical also facilitates expansion into Asia, where its newly signed partnerships with leading Taiwanese and South Korean clinical sites offer biotechs access to large, treatment-naïve patient populations — essential for fast Phase II and III recruitment.

For later-phase trials, Avance Clinical also provides a seamless expansion to its US-based operational and regulatory teams, ensuring continuity, quality oversight, and alignment with sponsor expectations throughout the development lifecycle.

"Our model is built specifically for biotechs — agile, science-driven, capital efficient and globally integrated," said Edwards. "From Australia to Asia to the US, we provide a single CRO partner to guide clinical programs from first-in-human to regulatory submission."