Cell & Gene Therapy

Conducting clinical trials in cell and gene therapy demands cutting-edge scientific expertise, robust safety protocols, and precise handling of innovative biotechnologies.

The unique complexities of these trials require seamless integration of advanced regulatory strategies, specialised logistics, and deep understanding of immunological responses. At iNGENū CRO, we combine scientific rigor with agile methodologies to deliver efficient, high-quality solutions to our global sponsors.

Common indications in which we have experience include:
  • CAR-T cell therapies for hematological malignancies
  • Gene editing therapies (CRISPR, TALENs) for genetic disorders
  • Stem cell therapies for regenerative medicine
  • Gene replacement therapies for rare genetic diseases

We collaborate with leading scientific experts, clinical investigators, and advanced technology platforms, ensuring comprehensive trial execution from design to long-term follow-up.

Disciplined,

Cost-Efficient Execution

while maintaining the Highest Quality

Local Trials,

Global Approvals

Access FDA Regulatory Expertise

Our Clinical Team has over

120

years

of Combined Clinical Trial Experience

Addressing Common Pain Points Associated with Cell & Gene Therapy Clinical Trials 

Navigating regulatory frameworks for cell and gene therapies can be highly complex and demanding.

iNGENū CRO addresses this pain point with Expert Regulatory Guidance

Our dedicated regulatory team provides comprehensive support from preclinical consultations through IND submissions and post-approval monitoring, ensuring seamless regulatory compliance.

Managing immune responses and adverse reactions associated with cell and gene therapies is critical.

iNGENū addresses this pain point with Advanced Safety Monitoring

We employ state-of-the-art immunological monitoring and real-time data analysis, with a dedicated safety board for immediate response and management of adverse events.

Cell and gene therapies require specialised handling, storage, and transport.

iNGENū addresses this pain point with Specialised Logistics Management

Our logistics team ensures seamless coordination of temperature-controlled logistics, real-time tracking, and handling procedures to maintain product integrity.

These therapies often necessitate extended patient follow-ups to evaluate long-term efficacy and safety.

iNGENū addresses this pain point with Patient Engagement Programs

We utilise long-term patient engagement and remote monitoring solutions to ensure consistent follow-up and high patient retention.

The iNGENū CRO Difference

iNGENu - FDA
Local Trials, Global Approvals

We uniquely combine Australian expertise with direct FDA submission capabilities, offering a streamlined path for sponsors to achieve global approval. Our seamless integration allows trial data from Australia to be submitted directly to the FDA via our E-Gateway, eliminating the need for third-party intermediaries.

iNGENu - cost efficient
Disciplined, Cost-Efficient Execution

iNGENū CRO takes a highly strategic and disciplined approach to clinical research, ensuring that every dollar is directed toward generating meaningful outcomes. Our trials are designed with efficiency in mind, eliminating unnecessary costs while maintaining the highest scientific and regulatory standards.

iNGENu - APAC
Australian-Headquartered, Asia-Pacific Reach

We provide sponsors with comprehensive trial capabilities across the Asia-Pacific region, offering a seamless combination of cost-efficiency and high-quality clinical trials. We leverage the region's competitive pricing while maintaining rigorous Australian-based project management and clinical oversight.

"We have been using iNGENū for a Phase 1, first-in-human trial of our investigational drug. We have used iNGENū for: Medical writing, project management, clinical data management and full end-to-end, clinical trial execution and monitoring.

We have been very happy with all aspects of the management of the clinical trial and have been particularly impressed by the out-of-the-box creative solutions to speed up and reduce overheads for our company during this clinical trial."

Giles Moss
Chief Executive Officer

iNGENu testimonial-logos-monotone-1

Ready to discuss your Cell or Gene Therapy Clinical Trial?

 
Ready to discuss your trial?