Bio-Venture company achieves simple and robust imaging workflows with cubeCDMS

Background

A Korean Bio-Venture sought a robust and flexible EDC system to manage its expanding oncology pipeline. For one of their Phase I/II solid tumor study involving 60 patients across 4 clinical sites, the sponsor was particularly concerned by the risk of inaccurate tumor assessment and the complexity of independent image review workflow. They required an EDC platform to manage RECIST/iRECIST evaluations, independent radiological reviews, and cycle-based treatment structures, all while ensuring full compliance with international regulatory standards.

The sponsor faced a series of data management and operational challenges typical of oncology studies:

To address these needs, the trial team consulted CRScube for a solution that would integrate image-based evaluations, automate response calculations, and support both clinical and radiological review teams, without compromising data quality or workflow flexibility.

Solution: cubeCDMS

Although the sponsor had options to select specialised tools to manage the complex imaging workflows, they decided to leverage CRScube’s cubeCDMS comprehensive oncology-specific functionalities, trusting our proven track record in imaging and independent review workflows.

This specific trial required a lot of tools that are typically used for tumor assessment and treatment cycles in oncology studies.

Imaging & Independent Review

• Capture and storage of DICOM imaging files directly within cubeCDMS.

• Configurable blinded independent read workflows, including reader assignment, read lock, reconciliation, and adjudication.

• Lesion tracking across visits with differentiation of target, non-target, and new lesions, aligned with per-protocol limits.

• Built-in calculators for RECIST 1.1 and iRECIST, applying nadir and confirmation rules with automated system-suggested responses, while allowing manual override with justification.

Visit / Cycle Architecture

• Configurable cycle-based study structure, enabling accurate restaging and handling of unscheduled scans.

• Carry-forward of baseline lesions with the ability to re-baseline after progression or treatment cohort switch.

• Dose delay/modification controls linked to lab values, ECOG status, and toxicity rules for improved protocol compliance.

Calculations, Grading, and Checks

• Automatic change-from-baseline/nadir calculations, Best Overall Response (BOR) derivation, and progression flagging.

• Built-in windowing checks and missing scan alerts to maintain data completeness.

• Cross-form consistency checks, ensuring alignment between tumor response entries and new-lesion documentation.

Results

By implementing cubeCDMS, the sponsor successfully enabled Independent Radiological Review using raw DICOM files, ensuring unbiased and reliable endpoint evaluations. The system’s oncology-specific architecture allowed the sponsor to maintain clarity and traceability throughout imaging assessments and treatment cycles.

Key outcomes included:

The sponsor also felt confident with the level of compliance tools provided by cubeCDMS:

• Full audit trail and 21 CFR Part 11 / Annex 11 compliance

• Role-based blinding and medical review workflows

• Data security and access supporting regulatory and inspection readiness

Conclusion

Through its dedicated oncology functionalities, cubeCDMS enabled this Korean Bio-Venture to achieve technical reliability, efficiency, and data confidence not only on this specific trial, but across three distinct oncology programs. The platform’s ability to seamlessly manage imaging, lesion tracking, and cycle-based workflows has made it a trusted cornerstone in the sponsor’s ongoing clinical development strategy.

CRScube’s continued collaboration with the sponsor demonstrates the value of an adaptable EDC platform that evolves alongside complex oncology research.