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.

Pain points associated with clinical trials in oncology

  • 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.
  • 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.
  • 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.
  • Complex Trial Designs: Oncology trials frequently involve intricate designs with a focus on specific genetic mutations, combination therapies, or patient subtypes.
  • 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.

How iNGENū addresses these pain points

  • 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.
  • 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.
  • 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.
  • Specialized Oncology Trial Design: Recognizing 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.
  • 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.
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