Clinical Trial Support

Specializing in global clinical trial establishment, design, development and submission.

Pipetting cell therapy in flask

Cell Therapies is uniquely placed to facilitate clinical trial supply in Australia and worldwide

We specialize in enabling global clinical trial establishment, assisting with clinical design, protocol development and regulatory submission. We can serve as a regional logistics storage hub for distribution to worldwide clinical sites including the Asia-Pacific region and rest-of-world.

The clinical trials expert

Our expert team is dedicated to delivering clinical trials in Australia and globally

Clinically integrated

We are integrated into Australia’s well-developed healthcare system and have extensive experience delivering to clinical trial sites across Australia, and worldwide.

Regulatory (PIC/S) compliance

Our products meet global regulatory and international organization for standardization (ISO) standards benchmarked by the Pharmaceutical Inspection Convention/Cooperation Scheme (PIC/S).

Fast regulatory approvals

The Therapeutics Goods Administration (TGA) in Australia offers two tracks for clinical trial establishment including an expedited regulatory approvals “Clinical Trial Notification” scheme.

Cryostorage and rapid logistics

We have the capacity to maintain thousands of patient collections and final products on-site in GMP conditions with the logistics capabilities to deliver treatments all over the world.

Strong clinical networks

We have strong relationships with clinicians around Australia and globally that are key to efficient clinical trial establishment across multiple sites.

Global experience

We have established multi continental manufacturing networks to support trials concurrently registered in Europe, Asia and North America.

Supporting your global clinical trials with 18 years of expertise

cell therapies support clinical trial submissions to regulatory agencies all over the world, including the US and European countries. Additionally, our alliance with PharmaBio Corporation in Japan simplifies the extension of clinical trials into the burgeoning Japanese market, with potential to access the attractive Japanese conditional approval pathway for regenerative medicine products.

Quality testing in the facility
Cell therapy under the microscope

Australia is a prime location for cell and gene therapy clinical trials

cell therapies is centrally located within the Peter MacCallum Cancer Centre, Australia’s leader in cellular immunotherapy treatment. We are wholly integrated into Australia’s well-developed healthcare system with access to a multitude of clinicians who specialize in various therapeutic areas, from cancer to infectious diseases to metabolic diseases.

Regulatory pathways for clinical trials in Australia

Australia offers an expedited pathway to clinical trials via the Clinical Trial Notification (CTN) scheme. Most clinical trials, including those that have already been established in the US under an IND or in Europe under a CTD can rapidly be extended to Australia through the Clinical Trial Notification (CTN) scheme that requires only clinical site Ethics Committee review prior to study commencement. This can take as little as 1 month from submission, with no regulatory agency review.

For the small number of proposed studies that do not qualify for the CTN process, the Australian TGA will review a detailed dossier application, in addition to Ethics Committee review, prior to study commencement per the Clinical Trial Approval (CTA) pathway.

Cell culture in the hood

Clinical Trial Notification (CTN)

  • Process
  • Ethics review + 14 days for TGA to issue CTN number
  • Limit CMC required
  • Applicable
  • First in human studies (except gene modified)
  • Studies with US IND or EU CTD approval
  • Opportunity
  • Fastest route to clinic anywhere
  • Generate clinical data for IND
  • Rapid extension/expansion of multi-center clinical trails

Clinical Trial Approval (CTA)

  • Process
  • Ethics review + TGA (9-12 months)
  • Full CMC required (as for IND)
  • Applicable
  • Any product where ethics committee feels unqualified to evaluate
  • Gene modified products
  • Opportunity
  • Procedures GMP certification of manufacturing that is often required in Asian jurisdictions
  • <10% of all Australian clinical trials

Contact the Cell Therapies Team today

Call Cell Therapies on +61 3 8559 7310 to talk to our expert team or enter your details below and we will contact you to arrange a call at a time that suits you.

Explore our services

Cell Therapies has extensive experience in the development and commercialization of cell and gene therapies for the Australian and global markets.

Apheresis Management

We can help you with apheresis collection protocol development, site selection and assessment, network management, cryostorage, and distribution

Contract Manufacturing

We provide rapid technology transfer, process development, manufacturing optimization, clinical trial and commercial product supply to global markets

Consulting and Advisory

Our experts advise on Chemistry, Manufacturing, and Control (CMC), Australian and international regulatory standards and requirements, and clinical program development