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Preclinical strategy
The groundwork that decides how quickly a study reaches the clinic.
- Market intelligence & feasibility
- Indication & model selection
- Vendor & academic partnerships
- Strategic consulting
Clinical trials
Your early-phase study, run end to end
One team handles every step, so nothing waits on a hand-off between vendors.
Our CRO team in Sydney handles feasibility, ethics, regulatory notification, site activation and monitoring, with PK/PD bioanalysis in our own laboratory. One contract, one project lead, one timeline.
How we get your study running
From protocol to first participant dosed, with one team accountable.
Step one
Feasibility & proposal
Site and population feasibility, a budget and a start-up plan for your compound.
Step two
Ethics, Regulatory & Study Start-Up
Ethics submission, Australian local sponsorship, CTN notification, site contracts and investigational product readiness.
Step three
Clinical Trial Delivery
Site activation, participant dosing, clinical monitoring, medical and safety oversight, data management and ongoing study coordination.
Step four
PK/PD Analysis to Final CSR
Bioanalysis in our Sydney laboratory, PK/PD analysis, followed by integrated study reporting and the final Clinical Study Report (CSR).
What we do, by stage of development
Most programmes reach us before first-in-human, but we can pick up a study at any stage of development.
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Phase I & first-in-human
From protocol to first participant dosed, with one team accountable for delivery.
- Trial design & site identification
- Regulatory submissions & site management
- Clinical monitoring
- Data management & biostatistics
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Phase II & decentralised trials
Scaling a programme beyond the first cohorts, in Australia and across the group.
- Inclusive patient recruitment
- Decentralised trial management
- Point-of-care diagnostics & telemedicine
- e-Documentation & logistics optimisation
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The regulatory route, handled
Every trial in Australia needs a local sponsor entity and ethics approval before the TGA is notified. We prepare the submissions and manage the timeline around them.
- Human Research Ethics Committee submission and responses
- Australian local sponsor arrangements
- CTN notification to the TGA
- Import and release of your investigational product
- Site contracts, training and ongoing monitoring
General information about the Australian pathway, not legal or regulatory advice.
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Bioanalysis
under
the same
roof
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