Pharma · CRO · Clinical Research

Structured imaging endpoints
your trial data actually needs.

Stop treating radiology reports as narrative text. RADIEWCARE + QUIBIM deliver structured, coded, FHIR-ready imaging data with 400+ quantitative biomarkers — ready for regulatory submission and AI-driven analysis.

GDPR-compliant multi-centre imaging  ·  IECC structured endpoints  ·  QUIBIM 400+ imaging biomarkers

400+
Imaging biomarkers
FHIR
Regulatory-ready output
Multi
Centre experience
GDPR
Compliant by design

Imaging data in clinical trials is broken

Unstructured narrative reports

Free-text radiology reports cannot be queried, aggregated or fed into statistical models without expensive manual extraction.

Inconsistent multi-centre reporting

Different radiologists, different centres, different terminology — making cross-site data harmonisation a major bottleneck.

Biomarkers buried in PDFs

Quantitative imaging biomarkers (tumour volume, ADC, SUV, texture features) are described in text but never captured as structured data points.

RADIEWCARE + QUIBIM: structured imaging from day one

IECC-structured imaging endpoints

Every imaging finding captured as a structured, coded data object — queryable, aggregatable and ready for statistical analysis.

Harmonised multi-centre reporting

Standardised IECC templates ensure consistent data capture across all trial sites, regardless of local radiologist or RIS platform.

400+ quantitative biomarkers

QUIBIM radiomics platform extracts and quantifies imaging biomarkers at scale — tumour volume, perfusion, texture, molecular prediction.

400+ imaging biomarkers across all major oncology indications

Via our strategic alliance with QUIBIM, we deliver quantitative radiomics and radiogenomics analysis for the most relevant molecular targets in precision oncology.

🫁 Thoracic Oncology

EGFR mutationKRASALK rearrangementPD-L1 expressiontumour volumeground glass ratioFleischner categorynodule densitypleural invasion

🧠 Neuro-Oncology

IDH mutationMGMT methylationBRAF V600Etumour perfusionADC mappingenhancement patternRANO criteriaperitumoral oedema

🎗️ GI & Abdominal

liver lesion characterisationRECIST 1.1iRECISTHCC stagingpancreatic duct dilationvascular involvementlymph node mapping

All biomarkers are evidence-graded (Level A–C), SNOMED CT coded and delivered as structured FHIR DiagnosticReport resources.

Request the full biomarker catalogue →

How pharma and CROs use RADIEWCARE

🔬

Phase II/III Oncology Trials

Structured imaging endpoints (RECIST, iRECIST, volumetric) captured consistently across all trial sites. Biomarker extraction for companion diagnostic development. FHIR-ready data for regulatory submission packages.

RECIST 1.1 iRECIST companion diagnostics
🧬

Radiogenomics & Biomarker Discovery

Correlate imaging features with genomic data (EGFR, KRAS, BRAF, PD-L1) to develop non-invasive biomarkers. Texture analysis, perfusion mapping and molecular prediction at scale.

radiogenomics liquid biopsy correlation texture analysis
🏥

Real-World Evidence Studies

Retrospective and prospective structured imaging data from real clinical settings. Multi-centre cohorts with harmonised IECC reporting. Linkable to EHR and genomic databases.

RWE retrospective cohorts EHR linkage
🤖

AI Model Training & Validation

High-quality structured imaging datasets with expert radiologist annotation and biomarker labels. Ideal for training and validating diagnostic AI models for regulatory submission.

annotated datasets AI training FDA/EMA alignment

Built for regulatory environments

🔒

GDPR Compliant

Data processed under EU GDPR. Anonymisation and pseudonymisation protocols. Data processing agreements available.

📋

Audit Trail

Full traceability per study: radiologist ID, timestamp, version history, quality flags. Exportable for regulatory dossiers.

🌐

HL7 FHIR Output

All structured data delivered as FHIR DiagnosticReport resources. Compatible with major EDC and regulatory submission platforms.

🏛️

Multi-Centre Ready

Harmonised IECC templates ensure consistent data capture across all sites. Central quality review available.

Ready to structure your trial's imaging data?

Tell us about your study — indication, phase, imaging modalities and endpoints. We will come back with a concrete proposal for structured imaging data collection and biomarker analysis.

info@radiewcare.com · Response within 24 hours