We would welcome the opportunity to explore your research program in greater detail and discuss how our expertise at Linear can support your transition from laboratory to human clinical trials.
Maximise your trial's success with Linear's mutli-site, multi-phase capabilities, expedited participant enrolment, and extensive network of subject matter experts.
Linear is at the forefront of innovation in clinical research, investing in technology and facilities across the full spectrum of trials, from first-in-human healthy volunteer trials, through to next generation trials including cellular/CAR-T therapy. Our comprehensive service offering caters to both domestic and international sponsors, providing:
- Strategic project planning and protocol development for Phase 1-4 clinical trials
- Australia’s first licensed, private hospital solely dedicated to next generation clinical trials – the Advanced Clinical Trial Centre (ACTC)
- Expedited recruitment through our data driven approach, or via our extensive network of clinicians, investigators and collaborators
- Advanced nursing, safety, and care services prioritising participant welfare
- On-site pharmacy, medical facilities, crash carts, QA resources, and real-time quality control
Perth, Western Australia – Our hub for clinical trials offers the perfect blend of academic excellence, world-class healthcare infrastructure, and a thriving research community. With over 2.6 million residents and employing over 40,000 health professionals, Perth is emerging as a major medical research destination, providing our clients with unparalleled access to cutting-edge facilities and expertise.
How might you benefit?
Clinical Trial Performance
Your Clinical Trial Journey
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We would welcome the opportunity to explore your research program in greater detail and discuss how our expertise at Linear can support your transition from laboratory to human clinical trials.
Our team can develop a preliminary strategy and estimate costs based on limited information from you. To proceed with a comprehensive proposal, provide a protocol synopsis and key trial objectives, along with a timeline for milestone achievements.
Linear undertakes a rigorous review process to ensure protocols meet Australian regulations’ highest standards of ethics and operational readiness. Consent Forms (PICFs) are crafted in accordance with approved terminology to streamline the Ethics process, and concurrent site set-up enables swift site activation.
Our collaborative approach with sponsors facilitates seamless communication, while our flexible solutions cater to the unique needs of each project, setting us apart from the competition.
Your Clinical Trial Journey
Our team can develop a preliminary strategy and estimate costs based on limited information from you. To proceed with a comprehensive proposal, provide a protocol synopsis and key trial objectives, along with a timeline for milestone achievements.
Linear undertakes a rigorous review process to ensure protocols meet Australian regulations’ highest standards of ethics and operational readiness. Consent Forms (PICFs) are crafted in accordance with approved terminology to streamline the Ethics process, and concurrent site set-up enables swift site activation.
Our collaborative approach with sponsors facilitates seamless communication, while our flexible solutions cater to the unique needs of each project, setting us apart from the competition.
Tailored solutions for complex clinical trials, engineered for speed, quality and precision.
More than a place to conduct trials – a partner in your entire clinical research journey. We facilitate every step of your clinical journey, from design to delivery and provide expert guidance on Australia’s innovative clinical trial frameworks, including the fast-track trial pathway and generous R&D incentives.
Unlock new frontiers in healthcare together
Our team is dedicated to supporting your trial goals and delivering results that matter.
We provide valuable strategic insight to optimise your trial within TGA regulations while keeping your bottom line in check. We can assist navigating the favourable tax environment that makes Australia the ideal place to conduct clinical trials.
As a purpose driven organisation, we are willing to invest in the greater good
With a long term mindset, we invest in the state-of-the-art facilities, cutting-edge technology, and expertly curated infrastructure to enable us to deliver trials that are faster, more efficient, and yield the most accurate results possible from Phase 1 trials to patients.
We were thoroughly impressed with the world class service; the execution of the trial was excellent, the project was completed ahead of schedule.
We have worked closely with Linear and leading cardiometabolic expert, Professor Gerald Watts across multiple programs spanning phase I to III. The expertise of Professor Watts, Linear’s world class facilities, and the favourable regulatory environment in Australia have helped advance these important programs to where they are today.
Frequently asked questions from Sponsors
Feel confident that you’ll be well cared for when choosing Linear to run your clinical trial.
What are the benefits for international clients conducting clinical trials in Australia?
No IND required, fast-track approvals, and streamlined processes mean Australian trials can be up to 4-6 months faster than their US counterparts. Plus, with generous R&D incentives from the Australian Government, you can reduce costs by up to a third.
At Linear, our concept-to-commercialisation expertise will guide you every step of the way, helping you navigate the complexities of clinical research and therapy development. And with our cash back for R&D expenses program, you’ll be rewarded for investing in innovation.
Is the data from Australian clinical trials applicable to U.S. regulatory submissions?
Yes, clinical trial data from Australia is highly regarded and accepted by international regulatory agencies, including the U.S. FDA. Australian clinical trials adhere to ICH-GCP guidelines, ensuring the quality and integrity of the data meet global standards.
Can Linear ship biological samples internationally?
Yes, Linear is experienced in handling and shipping biological samples internationally. We comply with international shipping standards and manage the logistics to ensure sample integrity is maintained throughout the process. This includes using appropriate packaging, temperature controls, and expedited shipping services to meet regulatory and research timelines.
How do I obtain a CTN (Clinical Trial Notification) acknowledgment?
To obtain a CTN acknowledgment, sponsors submit the necessary trial documentation to the TGA via an online portal. The sponsor must ensure that the trial is ethically approved by a Human Research Ethics Committee (HREC) before submitting the CTN. Once submitted, the TGA acknowledges the notification, typically within days, allowing the trial to commence without further regulatory delays.
What is the R&D Tax Incentive in Australia, and how can sponsors benefit from it?
The R&D Tax Incentive in Australia offers generous rebates to companies conducting research and development activities. Eligible clinical trial sponsors can claim up to 43.5% of their R&D expenditure as a refundable tax offset. This incentive helps reduce the financial burden of running trials and encourages sponsors to invest in innovative research within Australia.
What are the key roles and responsibilities for Linear and a CRO on a single-site trial?
Task |
Linear |
CRO |
Overall Project Management |
Responsible for project delivery at site level | Responsible for overall project management, including trial master file (TMF) and vendor management |
Regulatory & Start-Up |
Review protocol and IB, develop ICF, HREC submissions |
Local sponsorship, if needed. Can take on CTN and clinical trial registry, if requested by sponsor |
IP Management |
Labelling (if required), randomisation, dispensing, storage and destruction (if required) | Import/export licenses (if needed) |
Site Management |
Responsible for all site-level activities |
Responsible for clinical study monitoring |
Medical Monitoring and Safety Reporting | – |
Responsible |
Data Management & EDC |
Responsible for site-level data entry and management only |
Responsible for overall study DM, including eCRF design and implementation |
Medical Writing |
– | Protocol, IB and CSR development (if required) and review |
Biostatistics | – | Responsible (including PK/PD statistical analysis) |
Laboratory analysis | Responsible for safety pathology and processing of samples to be shipped to PK/PD bioanalytical lab |
Contracting and management of bioanalytical lab |