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?

Australia provides a streamlined regulatory process, enabling swift entry into human clinical trials through its clear and favourable Therapeutic Goods Administration (TGA) guidelines. Additionally, the country offers a competitive tax environment, creating an attractive setting for biotechnology and life science companies to establish and conduct research.
Accelerated start-up
Generous Australian R&D tax incentives
Integrated trial, lab and medical teams
Optimised timeframes and costs
Collaborative protocol and trial design

Clinical Trial Performance

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Cohorts dosed on time in FY24
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Beds
Clinical capacity for Healthy Volunteer studies, in addition to our Advanced Clinical Trial centre for patient trials
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Phase 1 / 1b clinical trials conducted at Linear

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.

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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.

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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.

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We were thoroughly impressed with the world class service; the execution of the trial was excellent, the project was completed ahead of schedule.

Professor Daria Mochley-Rosen
SPARK at Stanford
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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.

Dr. James Hamilton
Arrowhead Pharmaceuticals
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Frequently asked questions from Sponsors

Feel confident that you’ll be well cared for when choosing Linear to run your clinical trial.

Our Facilities

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.

Contact our team to learn more.

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