Therapeutic Expertise
Cell & Gene Therapy
We support advanced therapy programmes — CAR-T, gene therapies and other ATMPs — where manufacturing, complex safety profiles and long-term follow-up demand specialist trial management.
Cell and gene therapy trials combine complex logistics (chain-of-identity and chain-of-custody), distinctive safety events such as cytokine release syndrome, and regulatory requirements for extended long-term follow-up. Our physician-led team builds protocols and safety frameworks purpose-fit for these first-in-class modalities.
Addressing common pain points in cell & gene therapy clinical trials
Chain-of-identity and logistics
Autologous therapies require flawless tracking from apheresis to administration.
We implement validated tracking and site training to protect product integrity end to end.
Novel, acute safety events
Events like CRS and neurotoxicity require specialised recognition and management.
Our physicians build modality-specific safety monitoring and management plans.
Long-term follow-up requirements
Regulators require years of follow-up for gene-modified products.
We design retention and follow-up systems to meet extended regulatory expectations.
The iNGENū CRO difference
Australian expertise, direct FDA submission
We uniquely combine Australian expertise with direct FDA submission capabilities, offering a streamlined path for sponsors to achieve global approval. Trial data from Australia can be submitted directly to the FDA via our E-Gateway, eliminating the need for third-party intermediaries.
iNGENū takes a highly strategic and disciplined approach to clinical research, ensuring every dollar is directed toward generating meaningful outcomes — eliminating unnecessary costs while maintaining the highest scientific and regulatory standards across the Asia-Pacific region.
“We have been using iNGENū for a Phase 1, first-in-human trial of our investigational drug — medical writing, project management, clinical data management and full end-to-end execution and monitoring. We have been particularly impressed by the out-of-the-box creative solutions to speed up and reduce overheads during this clinical trial.”
Giles MossChief Executive Officer
Ready to discuss your Cell & Gene Therapy clinical trial?
Talk to our team about how iNGENū CRO can accelerate your research.
Request a proposal