STAGE 3: SUCCESS
Clinical Trials
Clinical Trials
Where readiness meets regulation: we take your product to trial stage, quickly and compliantly.
Where readiness meets regulation: we take your product to trial stage, quickly and compliantly.
Making clinical
trials less of a trial
Making clinical
trials less of a trial
Our team makes sure trials are conducted to the highest global GCP standards while maintaining efficiency and compliance. And because we truly understand clients' products and have developed them since the research phase, we know how to get the best clinical outcomes.
Our team makes sure trials are conducted to the highest global GCP standards while maintaining efficiency and compliance. And because we truly understand clients' products and have developed them since the research phase, we know how to get the best clinical outcomes.
The medicines we cover
Our specialist areas are nasal, respiratory and sleep, but we can accommodate a wide range of medicines.
Our Clinical Trial services
How we help you make it to market faster and safer.
01
Design &
regulatory
support
- Protocol development and study design
- Regulatory submissions (ethics committees, TGA/FDA/EMA)
- Preparation of investigator brochures and trial documentation
02
Site & patient
management
- Site selection and initiation
- Patient recruitment strategies and enrolment support
- Trial monitoring and site coordination
- Investigator and staff training
03
Operational &
logistical support
- Clinical trial supply management (packaging, blinding, labeling, distribution)
- Randomisation and trial tracking systems
- Coordination of investigational medicinal product (IMP) logistics
04
Data management
& analysis
- Case report form (CRF) design and electronic data capture
- Data monitoring, cleaning, and statistical analysis
- Safety reporting and pharmacovigilance
01 / 02
ABINITIO translated our novel sleep therapy from bench science to GMP manufacturing and into clinical trials with remarkable speed and precision. Their integrated CDMO and CRO capability removed friction at every step, turning complex science into a clinic ready reality. It is rare to find a partner that truly understands discovery, manufacturing, and trials as one continuous pathway.”
Tim Tyndale
CEO, Morpheus Health
02 / 02
ABINITIO created a dosing strategy for our inhaled NCE that opened a clinical path previously considered not viable. Their development of the final inhaled dosage form ensured seamless progression into first in human studies.”
Tom Wu
Principal, Apros Pharma
THE AUSTRALIAN ADVANTAGE
THE AUSTRALIAN ADVANTAGE
Why work with an Australian firm?
Why work with an Australian firm?
01
Tax rebate
Experience success for less. You can receive up to 43.5% of your R&D spend back as part of the Research & Development Tax Incentive offering if your company’s aggregated turnover is below $20 million. If it’s above that level, your rebate is 38.5%.
02
Global market access
When you go with Australia, you can go global. Australia’s strategic partnerships and strong adherence to international standards mean that Australian clinical trial data and regulatory approvals are recognised all over the world, facilitating smoother transitions to international markets.
03
Robust research ecosystem
Australia is home to world-class universities, hospitals, clinical trial facilities, and research institutes. Together, these institutions boost innovation, enhance the scientific credibility of clinical trials, and bring about faster progress towards clinical trial.
04
Efficient regulatory environment
Australia’s Therapeutic Goods Administration (TGA) offers clear guidelines and streamlined processes for clinical trial approvals. This efficiency accelerates the pace from conception to trial, idea to impact, reducing time and cost.