Start Your Phase I Clinical Trial Faster.
For Less.
With Globally Accepted Data.
Australia’s regulatory environment, cost advantages, and world-class bioanalytical infrastructure make it one of the most compelling destinations for early-phase clinical development. Resolian’s purpose-built Brisbane lab puts all of it within reach.
FASTER START
4–5 week HREC approval
(site-dependent).No IND required.
SIGNIFICANT SAVINGS
43.5% government R&D rebate.
At least 60% cheaper than the US.
WORLD-CLASS DATA
FDA and EMA accepted data. NATA-accredited GLP facility.
Why Leading Biotechs Choose Australia for Phase I
Australia has become the go-to jurisdiction for early-phase clinical trials.
The combination of a streamlined regulatory pathway, significant government incentives, and a world-class life sciences infrastructure means you can generate high-quality, globally accepted clinical data in less time and at substantially lower cost than in the US or Europe.
No IND. No Waiting.
In Australia, you don’t need an Investigational New Drug (IND) application to begin Phase I trials.
The Clinical Trial Notification (CTN) pathway offers one of the fastest regulatory approvals in the world, with HREC approval typically achieved within 4–5 weeks.
For many biotechs, that translates to months saved before a single patient is enrolled.
A 43.5% Government Rebate Changes the Economics
Eligible companies conducting clinical trials in Australia can access a 43.5% cash refund on qualifying R&D expenditure through the Australian Government’s R&D Tax Incentive programme.
Studies consistently show Australia is at least 60% cheaper than the US once incentives are applied.
For early-stage biotechs managing tight budgets, that difference is decisive.
Globally Accepted. Regulatory Ready.
Australia is an OECD member.
Data generated here is accepted by the FDA, EMA, and other major regulatory authorities worldwide.
Resolian’s Brisbane facility is NATA-accredited under GLP, ensuring your Phase I data meets the highest international standards and transitions seamlessly into your global submission package.
A Purpose-Built Lab at the Heart of Australia's Fastest-Growing Clinical Trials Region
Resolian Bioanalytics Brisbane is a 2,000 m² state-of-the-art facility,
purpose-built for pre-clinical and clinical bioanalysis.
Located in Brisbane, Australia, and staffed by a team of experienced scientists,
our lab is designed to move fast without compromising on quality.
NATA-accredited. GLP-compliant. Ready for your Phase I.
Address: 34 Corporate Dr, Cannon Hill QLD 4170, Australia | +61 (7) 3522 2110
See the Lab for Yourself
Take a guided video tour of our Brisbane facility and see the instrumentation, workflows,
and team that will support your clinical programme.
Watch the Lab Tour →
Small Molecule LC-MS/MS
Sciex 7500 QQQ and Sciex 6500+ QQQ platforms for precise small molecule quantitation.
Immunoassay
MSD SQ120 and Biotek multi-mode readers supporting PK, biomarker, and immunogenicity assays.
Flow Cytometry & Cell-Based Assays
Beckman Coulter Cytoflex instruments, biosafety cabinet, CO2 incubator – full cell and gene therapy support capability.
PCR
PCR thermocycler for molecular assay support.
PBMC Isolation
Sample kitting and PBMC separation workflows to support immunology programmes.
LIMS & Data Integrity
Watson LIMS. Sciex OS. 21 CFR Part 11 compliant software throughout.
Comprehensive Bioanalytical Support, Pre-clinical to Clinical
From first-in-human studies to more complex multi-modality programmes,
our Brisbane team delivers the full range of bioanalytical services your Phase I trial requires.
Technologies
- Small Molecule LC-MS/MS
- Large Molecule LC-MS/MS
- Immunoassay
- Flow Cytometry
- PCR
- PBMC Isolation
Therapeutics and Testing
- Proteins and Oligonucleotides
- Cell and Gene Therapy
- Immunogenicity
- Biomarkers
- Clinical DDI Studies
- Peptide Analysis
Phase I in Australia. Phase II and Beyond, Wherever You Need.
Starting your programme in Australia doesn’t mean staying there. Resolian’s global network spans labs in the US, UK, and China. When you’re ready to progress to Phase II or III, we transfer your validated assays across sites using harmonised processes and a single, consistent quality standard.
One partner. One quality framework. No disruption to your programme.
Brisbane, Australia
Phase I
Malvern, USA
Phase I-III
Fordham, UK
Phase I-III
Chongqing, China
Phase I-III
Proven in Practice
CASE STUDY:
From Contract to First Patient in 12 Weeks: Resolian Delivers on Tight Timeline
A Chinese biotech study sponsor is conducting a clinical trial in AUS. The contract was signed in the November, and the First Patient In (FPI) was in early February.
CHALLENGES
- Four methods to be developed and validated before FPI
- Export reference materials and internal standards from China to Australia
- Timely Communication
- Language Barrier
SOLUTIONS
- Resolian’s Chongqing lab started method development while preparing shipping documents, which saved 3-4 weeks for the Brisbane lab to complete Method Development / Method Validation
- Chongqing Lab took care of export and shipping documents for the sponsor
- A direct message group with 2-way translation was implemented to facilitate easy communication and timely response
- Assigned a Chinese-speaking Project Manager to work with all stakeholders to avoid potential barrier
CONCLUSION
All methods were validated on time and the study was completed successfully!
Trusted by leading biotech and pharmaceutical companies, as well as local government and industry organizations.
Three Steps to Your Phase I in Australia
step 1:
Schedule a call
In a commitment-free consultation, we’ll understand your programme, your timeline, and the challenges you’re navigating.
step 2:
Receive a proposal
Resolian will build a proposal tailored to your specific assay requirements. We’ll also guide you through the Australian CTN process and connect you to the right partners at every step.
step 3:
Move Forward with Confidence
Our team delivers high-quality, GLP-compliant data that meets FDA and EMA standards — on time, every time.
Ready to start your Phase I in Australia?
Resolian’s Brisbane team is ready to support your early-phase clinical programme with world-class bioanalysis,
a NATA-accredited GLP facility, and seamless global continuity. Let’s talk.
