# Imaging core labs and central review

Source: https://onco.cc/technologies/imaging-core-labs/  
OnCo record `imaging-core-labs` (Technology). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Independent radiologists who re-read every scan in a trial the same way, so response rates mean the same thing across hospitals.

## Summary

Blinded independent central review (BICR) applies RECIST, iRECIST, Lugano, or PCWG3 criteria consistently across sites and is expected by regulators for PFS and ORR endpoints. Vendors: Calyx (formerly Parexel Informatics), ICON Medical Imaging, Clario (Bioclinica + ERT), Median Technologies, WCG Imaging, and Radiology Partners' research arm. AI-assisted lesion tracking and quantitative imaging biomarkers are entering the workflow.

## Fields

- Kind: Technology
- Status: standard-of-care
- Last checked: 2026-09-08
- Tags: supporting
- Principle: De-identified DICOM images uploaded to a central platform; two readers plus adjudicator score per protocol charter; discrepancy rates and read variability are tracked.
- Strengths: Endpoint integrity; Regulatory acceptance
- Limitations: Cost and turnaround; Discordance with local read (~30% of progression calls)

## Sources

- FDA guidance: clinical trial imaging endpoint process standards: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-trial-imaging-endpoint-process-standards-guidance-industry

## Connected records

- fronts: [Imaging](https://onco.cc/fronts/imaging/)
- technologies: [Contract research organisations (CROs)](https://onco.cc/technologies/contract-research-organisations/), [CT (computed tomography)](https://onco.cc/technologies/ct/), [PET/CT](https://onco.cc/technologies/pet-ct/), [Quantitative imaging biomarkers (RECIST, PERCIST, SUV, ADC)](https://onco.cc/technologies/quantitative-imaging-biomarkers/)
- companies: [Calyx](https://onco.cc/companies/calyx/), [Clario](https://onco.cc/companies/clario/), [ICON plc](https://onco.cc/companies/icon-plc/), [Medpace](https://onco.cc/companies/medpace/)
- terms: [Blinded independent central review (BICR)](https://onco.cc/terms/bicr/), [RECIST](https://onco.cc/terms/recist/)
- roadmaps: [Trial modernisation roadmap: the randomised trial → platforms and adaptive designs → decentralised, pragmatic and always-on](https://onco.cc/roadmaps/trial-modernisation-roadmap/)

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