Support to enable global clinical trial requirements
The volume of clinical trials for cell therapies, gene therapies, regenerative medicines, and cellular immunotherapies is increasing globally at breakneck pace. Cell Therapies is uniquely placed to facilitate clinical trials supply in Australia. Our facility is centrally located within the Peter MacCallum Cancer Centre, amidst a precinct that also includes the Royal Melbourne, Royal Women’s and Royal Children’s Hospitals. This location enables access to a multitude of clinicians who specialise in various therapeutic areas, from cancer to infectious diseases to metabolic diseases, and clinical settings already familiar with cellular product handling and transplantation.
Most clinical trials, including those that have already been established in the US under an IND or in Europe under a CTA 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 Exemption (CTX) pathway.
We also happily support clinical trial submissions to regulatory agencies all over the world, including the US and European countries. 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.
CTPL specialises in enabling global clinical trial establishment by assisting with clinical design, protocol development, and regulatory submission. We can also act as the regional logistics hub for storage and distribution to Asia-Pacific clinical sites. Finally, in combination with our contract manufacturing services, we can be a single site solution for your clinical needs.
Please contact us today to get started.