Oncology
We understand the complexities of oncology trials and the challenges associated with recruiting patients.
Our oncology team brings vast experience across a variety of cancers, with expertise in:
- Solid tumors
- Hematologic malignancies
- Rare cancers
- Breast cancer and associated subtypes
We understand the complexities of oncology trials, including the use of advanced imaging techniques for tumor 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 clinical team has over
120
years of combined clinical trial experience
Local Trials,
Global Approvals
Access FDA regulatory expertise
Disciplined,
Cost-efficient execution
While maintaining the highest quality
Addressing Common Pain Points Associated with Oncology Clinical Trials
Advanced Imaging Techniques for Tumor Assessment
Accurate tumor assessment using advanced imaging is crucial but can pose challenges in terms of standardization, 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 standardized imaging practices across sites and provide continuous training for consistent interpretation.Biomarkers for Patient Selection
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 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
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 addresses this pain point with the 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
Oncology trials frequently involve intricate designs with a focus on specific genetic mutations, combination therapies, or patient subtypes.
iNGENū addresses this pain point with Specialized Oncology Trial Design
ecognizing 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
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.
Oncology Clinical Trial Resources
Understanding Ovarian Cancer Clinical Trials
Ovarian cancer is the fifth most prevalent cancer among women globally, presenting a significant challenge to both women's health and public health systems worldwide.
Read our whitepaper on epidemiology, clinical implications, and strategies for clinical trial success.
Acute Myeloid Leukemia Clinical Trials
AML is the most common type of acute leukemia in adults. Its management often involves a complex treatment approach.
Read our whitepaper to learn about clinical trial strategies.
Strategies for Breast Cancer Clinical Trial Success
Breast cancer remains one of the most common and impactful malignancies affecting women worldwide.
Learn about pivotal endpoints in Breast Cancer clinical trials and strategies for clinical trial success.
Understanding Bladder Cancer Clinical Trials
Bladder cancer is the tenth most common cancer worldwide, with higher prevalence in men than women, but it remains a significant global health challenge.
Read our whitepaper to learn about clinical trial strategies.
Prostate Cancer Clinical Trials
Prostate cancer stands among the most commonly diagnosed cancers worldwide, demanding ongoing efforts to enhance prevention, detection, and treatment strategies.
Read our whitepaper to learn about clinical trial strategies.
Key Strategies for Success in Lung Cancer Clinical Trials
Lung cancer is a leading cause of cancer death worldwide, highlighting the critical need for effective clinical trials to improve treatments.
Read our whitepaper to learn about clinical trial strategies.
The iNGENū CRO Difference
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.
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.
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
Ready to discuss your Oncology Clinical Trial?