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Western Australia

Linear Clinical Research

Australia and 2 other(s)
Linear Clinical Research provides the most comprehensive clinical trial site capability in Australia, delivered across three specialist facilities, including the purpose-built Joondalup Early Phase Centre and Australia's first private hospital dedicated to cancer and other therapeutic trials, the Advanced Clinical Trial Centre.Leveraging rapid trial start-up and eSource technology, Linear delivers trials across all phases in healthy volunteers and patient groups, including next generation molecules such as RNA, bi/trispecifics and cell therapy. Having delivered over 500 trials since opening in 2010, Linear has developed innovative practices across volunteer recruitment, data capture, quality assurance and medical governance.As a profit-for-purpose company and subsidiary of the Harry Perkins Institute of Medical Research, Linear is solely invested in the success of your clinical program. We hold dedicated Medical Directors across our core portfolios of Phase I healthy volunteer, oncology, haematology, immunology and cardiometabolic, with capability extending across a broad range of therapeutic areas, enabling critical protocol optimisation and medical recommendations tailored to your programme.Australia offers a uniquely compelling environment for early-phase development. A fast regulatory framework removes the need for an IND application, an experienced and drug-naive volunteer population supports clean, high-quality data, and eligible pre-revenue biotechs benefit from a 43.5% R&D cashback incentive, making Australia one of the most cost-competitive destinations for first-in-human research globally.
  • Clinical Trial Management and Support
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Contact person(s):
Year founded
2010
No of Employees
260-300
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New South Wales

Obatica Oncology & Medical

Australia
Obatica Oncology & Medical is a boutique medical focused drug development and clinical trial consultancy firm based in Sydney Australia. Services includes clinical development and commercialization strategy, clinical trial study design, medical writing, medical director, medical monitor, and pharmacovigilance services.Obatica has been involved in over than 60 clinical trial projects with sponsors from US, Canada, Singapore, EU, and Australia.Specializing in complex early phase clinical trials in Oncology, Allergy, Pain and Rare diseases. Our development experience includes small molecules, monoclonal antibodies, RNA-based therapies, cell therapies and radiotheranostics.Our Medical Writing team can produce a high quality and faster than industry standard clinical trial related documents such as synopsis, Investigational Brochure’s (IB), protocol, PICF, CSR, and regulatory related submissions for instance INTERACT, IND, DSUR.Obatica is a leading Medical and clinical trial Functional Service Provider (FSP) providing cost effective fractional allocation of practicing clinicians with clinical trials experience, providing senior medical director or sponsor medical representative roles.Our in-house specialist doctors include Medical Oncologists, General Medicine Physicians, Geriatricians, and Surgeons to support your project. Let’s have a free initial confidential chat about your drug development or clinical trial project.
  • Clinical Trial Management and Support
Working with:
Contact person(s):
Year founded
2021
No of Employees
5-10
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Queensland

Resolian Bioanalytics

Australia and 1 other(s)
Resolian is a global laboratory contract research organization that provides bioanalytical and analytical sciences support for drug development, preclinical, and multi-regional clinical trials, emphasizing exceptional solutions and strong collaborative relationships. The company offers services in drug metabolism and pharmacokinetics and bioanalytical, new drugs, metabolites or generic drug assays, large molecule immunoassays, small molecule metabolite profiling and identification and biosimilar characterization, thereby assisting clients through the process of taking a drug from pre-clinical trials to market at earliest.
  • Company Type (Public/Private)
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Contact person(s):
Year founded
2007
No of Employees
20-600
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Queensland

Acclime Australia

Australia and 3 other(s)
Acclime Australia supports international companies, particularly foreign businesses, looking to establish and scale operations in Australia while accessing the benefits of the Australian Research & Development Tax Incentive program (R&DTI).Our team of corporate, tax, and R&D specialists assists international companies across a broad range of industries to enter the Australian market efficiently and compliantly, while taking advantage of generous benefits for innovation and technology development.Our services include:Market entry and corporate structuring advisory - Assisting companies in selecting the most appropriate structure for their Australian operations, including subsidiary incorporation, branch registration, and cross-border tax considerations.Australian company establishment and registrations – Managing the setup of Australian entities, tax registrations, and Australian bank account support to ensure a smooth market entry process.Resident Director and company officers – Providing experienced Australian/industry-based officers to satisfy local regulatory and tax residency requirements.R&D Tax Incentive advisory - Supporting companies throughout the full R&D lifecycle, including eligibility assessments, technical and financial documentation, application preparation, and ongoing compliance management.Transfer Pricing advisory – Assisting multinational groups with transfer pricing compliance and advisory services to ensure cross-border related party transactions are aligned with Australian tax regulations and transfer pricing principles.Ongoing accounting, tax, payroll, and compliance outsourcing –Enabling international companies to operate in Australia without the need to build a large internal administrative function.Registered office and operational support solutions – Allowing overseas businesses to maintain a compliant local presence while managing operations remotely.With local teams across Australia, the USA, UAE, and the Asia-Pacific region, Acclime combines international business expertise with practical on-the-ground support to help innovative companies confidently expand into Australia and successfully navigate their growth journey.
  • Company Type (Public/Private)
Working with:
Contact person(s):
Languages
  • English
Year founded
2011
No of Employees
1-2,000
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New South Wales

Celosia Therapeutics

Australia
Celosia Therapeutics is a clinical‑stage biotechnology company developing disease‑modifying therapies for neurodegenerative disorders with high unmet need.
  • Advanced therapies including cell & gene
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Contact person(s):
Languages
  • English
Year founded
2022
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New South Wales

Clinrol

Australia
Clinrol offers an innovative platform that connects patients with tailored clinical trials globally, serving as a comprehensive recruitment solution for sponsors, researchers, clinics, biotechs, and pharmaceutical companies.
  • Company Type (Public/Private)
Contact person(s):
Year founded
2020
No of Employees
15-20
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Victoria

Global Pharma Solutions

Australia and 1 other(s)
Global Pharma Solutions (GPS): Experienced professionals accelerating medicine registrations globally. GPS is a global regulatory and product development consulting firm with experts in both the US and Australia. We have over 22 years’ experience in developing and registering hundreds of products including small molecules, biologics and medical devices and 11 years’ experience with cell and gene therapies, particularly liaising with the FDA.We guide biotech companies through complex development pathways, ensuring a clear route to market approval.Through our partner CROs, we also offer support with clinical operations.
  • Company Type (Public/Private)
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Contact person(s):
Year founded
2003
No of Employees
5-11
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Victoria

Invion Limited

Australia
Invion (ASX: IVX) is a clinical-stage Australian life sciences company developing its Next-Generation Photodynamic Therapy (NGPDT) for the treatment of a range of cancers. The technology is a precision cancer targeting therapy that is powered by light.It uses non-toxic photosensitisers activated by a specific wavelength of light to selectively kill cancer cells and promote an anti-cancer immune response.Highlights of our platform technology for treating cancers include:Selectively targets and kills cancer cells by taking advantage of the Warburg effect (i.e. cancer cells have high glucose uptake, so we structured our compounds around this)Activation of immune response including when combined with immunotherapies (immune checkpoint inhibitors) increased response rates from 12% to 80%We are undertaking clinical trials across multiple cancers and results so far show our treatments to be both safe and demonstrate efficacy signals (completed PoC Ph II prostate investigator led 40-44% response rates, ongoing Ph I/II non-melanoma skin cancer no pain and reduction in tumour size, upcoming anogenital - already awarded Orphan Drug Designation by FDA for anal cancers)Industry partners have already recognised the potential of our technology and are providing non-dilutive funding for a number of our programs (e.g. Hanlim Pharm for esophageal cancer with backing of the Korean Drug Development Fund grant)Expanding therapeutic targets beyond human cancers to eye diseases (e.g. Wet Age-Related Macular Degeneration) and companion animal cancers, where partners are funding preclinical studies and/or animal trialsPhotosoft has the potential to replace an old FDA approved PDT, Visudyne, for Wet AMD that has experienced a global shortage due to its complex chemistry and manufacturingTheragnostic potential where red light kills cancer cells while violet light causes fluorescence Potential for the therapy to be used against infectious diseases (e.g. superbugs) and fungi.Click the link below to some video interviews with our research partners, Peter MacCallum Cancer Centre and the Hudson Institute of Medical Research. https://inviongroup.com/videos-reports/.
  • Company Type (Public/Private)
Working with:
Contact person(s):
Languages
  • English
Year founded
2017
No of Employees
5-30
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New South Wales

MINIMUM bio

Australia and 1 other(s)
MINIMUM Bio is a Sydney-based drug-target discovery and proximity-inducing therapeutics company. Our proprietary Mercurious® platform uses phage-displayed cDNA libraries to identify, with no prior assumptions, which proteins in the human proteome bind any given bioactive compound. This agnostic, proteome-wide approach generates novel drug-target pairs faster and at lower cost than any competing technology — enabling both internal pipeline development and external partnering across oncology, immunology, and longevity.Our compound engine is built around the rapamycin scaffold. Rapamycin and its analogs (rapalogs) act as molecular glues, recruiting the abundant intracellular chaperone FKBP12 into proximity with a target protein to block its function — a clinically validated proximity-inducing mechanism. We are engineering the rapamycin polyketide synthase (PKS) to generate structural diversity across this scaffold, creating a growing library of rapalogs with tunable binding properties.PipelineOncology: Lead rapalog MB2052 has been confirmed to recruit FKBP12 to EP300, a master transcriptional co-activator dysregulated across multiple cancers and among the most compelling undruggable targets in oncology. Program status: early validation.Immunology: Rapalogs with improved mTORC1 selectivity are being developed as next-generation immunosuppressants with reduced metabolic liability versus rapamycin and FK506. A separate first-in-class rapalog recruits an undisclosed transcription factor to FKBP12, representing a novel immunomodulatory mechanism with no current clinical precedent. Program status: discovery.Longevity: mTORC1-selective rapalogs targeting healthspan extension with a reduced chronic side-effect profile relative to rapamycin. Program status: discovery.
  • Company Type (Public/Private)
Contact person(s):
Year founded
2022
No of Employees
5-9
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New South Wales

Mobius Medical

Australia and 1 other(s)
Mobius Medical is a Contract Research Organization (CRO) providing a turnkey solution, end-to-end service, for the management of clinical trials. Our focus is on medical device clinical trials and specifically Class II, III and active implantable medical devices. Our key focus is designing and implementing a clinical strategy specific to our clients' needs and their investigational product. Mobius conducts clinical trials in the United States, Australia and New Zealand.Australia has long been a destination for US companies wanting to conduct Early Feasibility Studies (EFS). With an expedited regulatory pathway taking 1-2 days to obtain approval, IRB approvals in 12 weeks, and a very competitive R&D tax incentive, US companies can obtain EFS data quickly to support IDE applications. With offices in Australia and the US, Mobius can seamlessly jump from a single center EFS study in Australia, to multicenter Pivotal studies incorporating sites across the US and Australia. At Mobius we focus on strategically design studies to expedite commercialization.
  • Company Type (Public/Private)
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Contact person(s):
Year founded
2008
No of Employees
25-35
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