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. We collaborate with leading scientific experts, clinical investigators, and advanced technology platforms, ensuring comprehensive trial execution from design to long-term follow-up.
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
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
Complex Regulatory Pathways
Problem:
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 omprehensive support from preclinical consultations through IND submissions.
Patient Safety and Immune Responses
Problem:
Managing immune responses and adverse reactions associated with cell and gene therapies is critical.
iNGENū CRO addresses this pain point with 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.
Logistical Challenges
Problem:
Cell and gene therapies require specialised handling, storage, and transport.
iNGENū CRO addresses this pain point with 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.
Long-term Follow-up
Problem:
These therapies often necessitate extended patient follow-ups to evaluate long-term efficacy and safety.
iNGENū CRO addresses this pain point with 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
Local Trials, Global Approvals
We uniquely combine Australian expertise with direct FDA submission capabilities.
Disciplined, Cost-Efficient Execution
iNGENū CRO takes a highly strategic approach to clinical research.
Australian-Headquartered, Asia-Pacific Reach
We provide sponsors with comprehensive trial capabilities.
We have been using iNGENū for a Phase 1, first-in-human trial of our investigational drug. We have been very happy with all aspects of the management of the clinical trial.
Ready to discuss your Cell & Gene Therapy Clinical Trial?