BaseBio Consulting supports global biotech sponsors to plan and deliver clinical trials in Australia through sponsor-side Fractional clinical operations leadership and local oversight aligned with ICH-GCP E6(R3) expectations.
We embed within sponsor teams as a fractional clinical operations function, providing vendor identification and selection, CRO oversight frameworks, study start-up coordination, and governance visibility across outsourced delivery. Our role complements execution partners by ensuring sponsors retain structured oversight, decision clarity, and inspection-ready documentation.
BaseBio also supports companies navigating Australia’s efficient regulatory pathways and the R&D Tax Incentive (RDTI) environment through on-the-ground operational leadership and vendor ecosystem alignment.
We work primarily with emerging US and EU biotechs establishing early-phase through Phase III programs in Australia.
Why work with us
BaseBio Consulting is an Australian sponsor-side clinical operations consultancy supporting global biotech and biopharma companies to establish and deliver clinical trials in Australia with clarity, oversight, and confidence.
We operate as an embedded extension of the sponsor team, providing fractional clinical operations leadership across the study lifecycle—from early feasibility and vendor selection through start-up, delivery oversight, and close-out. Our approach aligns with ICH-GCP E6(R3) expectations that sponsors maintain proportionate oversight of delegated activities while working with CROs, sites, and specialist vendors.
BaseBio supports sponsors by:
• Understanding the Australian vendor ecosystems which can be aligned to protocol, phase, and risk profile
• Managing CRO and vendor selection processes, including RFP development and bid-defence support
• Establishing sponsor oversight frameworks and governance visibility across outsourced delivery
• Supporting CTN/CTA pathway coordination and Australian regulatory lifecycle alignment
• Providing local sponsor-side operational leadership (“boots on the ground”) in Australia
• Supporting inspection-ready documentation structures and CtQ-aligned delivery oversight
Australia continues to be a strategic location for early-phase and global development programs due to its efficient regulatory environment, strong investigator networks, and internationally accepted clinical trial data. BaseBio helps sponsors navigate this landscape while maintaining sponsor accountability and decision-making visibility throughout execution.
We work primarily with emerging and mid-size US and EU biotechs entering Australia for FIH, Phase I/II, and global Phase II–III programs, and with companies seeking structured support aligning clinical delivery with the Australian R&D Tax Incentive (RDTI) environment.
Our role is not CRO execution—we provide the sponsor-side leadership layer that ensures execution partners operate within a clear governance framework.
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