Oncology
We understand the complexities of oncology trials and the challenges associated with recruiting patients.
We understand the use of advanced imaging techniques for tumour assessment, biomarkers for patient selection, and the integration of novel endpoints like progression-free survival and overall survival. We are also adept at managing the regulatory complexities associated with oncology trials, including those involving cutting-edge modalities like gene therapies and CAR-T therapies.
Our oncology team brings vast experience across a variety of cancers, with expertise in:
- Solid tumours
- Haematologic malignancies
- Rare cancers
- Breast cancer and associated subtypes
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
Oncology Clinical Trial Resources
Ovarian Cancer Clinical Trials
Understanding ovarian cancer epidemiology, clinical implications, and trial strategies for success.
Acute Myeloid Leukemia (AML) Clinical Trials
Innovative clinical trial strategies for AML, focusing on treatment response and survival outcomes.
Breast Cancer Clinical Trials
Strategies and pivotal endpoints for successful breast cancer clinical trials worldwide.
Bladder Cancer Clinical Trials
Understanding bladder cancer epidemiology, treatment advancements, and trial methodologies.
Prostate Cancer Clinical Trials
Exploring strategies to improve prostate cancer prevention, detection, and treatment outcomes.
Lung Cancer Clinical Trials
Key strategies for designing and executing successful lung cancer clinical trials globally.
Addressing Common Pain Points Associated with Oncology Clinical Trials
Advanced Imaging Techniques for Tumour Assessment
Problem:
Accurate tumour assessment using advanced imaging is crucial but can pose challenges in terms of standardisation, interpretation, and technological requirements.
iNGENū CRO addresses this pain point with Expertise in Advanced Imaging Interpretation:
iNGENū boasts a team of radiology specialists trained in the latest oncological imaging techniques. We ensure standardised imaging practices across sites and provide continuous training for consistent interpretation.
Biomarkers for Patient Selection
Problem:
The use of biomarkers to select suitable patients can be complex, given the vast number of potential markers and the need to validate them for accuracy and predictability.
iNGENū CRO addresses this pain point with Biomarker-Driven Patient Stratification:
Leveraging advanced laboratory partnerships, we emphasize the identification and validation of robust biomarkers. This enables precise patient selection, ensuring that the right patients receive the right treatments.
Integration of Novel Endpoints
Problem:
Progression-free survival (PFS) and overall survival (OS) are critical outcomes but can be tricky to define, measure, and interpret, especially when compared to more traditional endpoints.
iNGENū CRO addresses this pain point with Adoption of Advanced Endpoints:
Our team is skilled in integrating novel endpoints like PFS and OS. By using advanced analytical tools, we ensure accurate measurement, clear definition, and insightful interpretation of these outcomes to reflect the true efficacy and safety of oncological interventions.
Complex Trial Designs
Problem:
Oncology trials frequently involve intricate designs with a focus on specific genetic mutations, combination therapies, or patient subtypes.
iNGENū CRO addresses this pain point with Specialised Oncology Trial Design:
Recognising the complexities of oncology trials, iNGENū collaborates closely with sponsors to ensure study designs that are scientifically robust and tailored to the unique challenges and goals of cancer research.
Regulatory and Compliance Issues
Problem:
Due to the novel nature of many oncology treatments and methods, there’s heightened scrutiny from regulatory bodies, which makes compliance paramount.
iNGENū CRO addresses this pain point with Focused Regulatory Compliance for Oncology:
Our regulatory experts stay updated on the latest oncology-specific guidelines. Our proactive approach ensures that trials are always compliant, anticipating potential regulatory challenges and addressing them early.
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 Oncology Clinical Trial?