What is therapeutic imaging in clinical trials?

Therapeutic imaging involves using medical imaging to evaluate disease progression, treatment response, and clinical endpoints within a specific therapeutic area such as oncology, MSK, or CNS.

How does Image Core Lab ensure consistency in imaging reads?

We follow response criteria (e.g., RECIST, RAMRIS, and McDonald) and use standardized imaging protocols. All reads are performed by subspecialty radiologists and audited for quality.

What therapeutic areas do you cover?

We offer imaging services across oncology, musculoskeletal, gastrointestinal, cardiovascular, and central nervous system trials, with AI and SaMD validation support in each.

Can you support AI algorithm development for radiology?

Yes, Image Core Lab supports AI algorithm development for radiology. We provide expert-annotated datasets, image review services, and clinical validation support for SaMD and AI developers across multiple therapeutic domains.

Is your imaging workflow compliant with regulatory standards?

Yes. Our workflows comply with ICH-GCP, FDA 21 CFR Part 11, and HIPAA requirements for data integrity, patient privacy, and regulatory readiness.

Trusted Core Lab Partner
For Oncology Clinical Trials

Since 2012, Image Core Lab (ICL) has supported pharmaceutical companies and CROs conducting oncology clinical trials across hematologic malignancies and solid tumors.

From Phase I through Phase IV, ICL’s subspecialist radiologists provide protocol-driven image interpretation using established response criteria to support consistent, reliable imaging endpoints.

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Years of Expertise

Countries

Oncology Trials

Subjects

Sites

Timepoints

What Sets Image Core Lab Apart

Scientific Consistency

ICL’s board-certified radiologists and reviewers follow structured workflows to maintain consistency across readers, sites, and timepoints.

Radiologist reviewing medical imaging scans

Standardized response assessment workflow

Operational excellence centralized workflow

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How ICL Supports Your Oncology Clinical Trials

ICL’s pool of radiologists conducts centralized tumor response review for clinical trials using unblinded or blinded review models.

Radiologist reviewers interpret tumor response using RECIST 1.1 and disease-specific criteria matched to the trial protocol.
Clinical operations teams configure the review model, imaging workflows, quality checks, and adjudication process required for each study.
Imaging and operations teams develop your Imaging Review Charter and prepare sites for imaging readiness before the first patient is enrolled.

End-to-End Imaging Core Lab Workflow

A structured process supporting imaging quality, data integrity, and reliable study delivery.

Depth Across the Oncology Landscape

Oncology is the cornerstone of Image Core Lab’s therapeutic focus. Its portfolio spans solid tumors, hematologic malignancies, and advanced disease settings, with concentrated experience in lung cancer and lymphoma and lymphoid malignancies.

ICL’s board-certified radiologists bring expertise across disease biology, therapeutic mechanisms, and response assessment methodology.

Reviewers apply RECIST 1.1, iRECIST, and irRC for solid tumors, with specialized criteria for specific indications, including RANO for glioma, iwCLL for chronic lymphocytic leukemia, mRECIST for liver, LUGANO for lymphoma, IMWG for multiple myeloma.

By applying the appropriate response criteria and specialized interpretation to each indication, ICL helps generate imaging endpoints that contribute to understanding treatment response and the therapies that can improve patient outcomes and quality of life.

Indication-Specific Response Criteria CL's radiologists bring expertise in applying established response criteria across diverse tumor types and hematologic malignancies.

Focus Area	RECIST 1.1	iRECIST	irRC	LUGANO	IMWG	RANO	iwCLL
Bladder	Z	Z	Z	-	-	-	-
Breast	Z	Z	Z	-	-	-	-
Colorectal	Z	Z	Z	-	-	-	-
Glioma	-	-	-	-	-	Z	-
Kidney	Z	Z	Z	-	-	-	-
Leukemia	-	-	-	-	-	-	Z
Lung	Z	Z	Z	-	-	-	-
Lymphomas	-	-	-	Z	-	-	-
Melanoma	Z	Z	Z	-	-	-	-
Myeloma	-	-	-	-	Z	-	-
Ovarian	Z	Z	Z	-	-	-	-
Pancreatic	Z	Z	Z	-	-	-	-
Prostate	Z	Z	Z	-	-	-	-
Stomach	Z	Z	Z	-	-	-	-

CLINSpa for Oncology Trial Imaging Management

ICL’s proprietary clinical trial imaging platform, CLINSpa defines how imaging data is stored, secured, and delivered. It is built for oncology workflows from standardized review through audit-ready reporting.

The platform is HIPAA-compliant, and its image viewer is FDA 21 CFR Part 11 compliant.

CLINSpa combines expert image interpretation with a secure, cloud-based architecture, supporting drug development through a global reviewer network working across time zones.

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Full Audit Trails

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Secure Cloud Architecture

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Customizable Workflows

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Automated Computation

ICL Clinical Leadership

Dr. Arjun Kalyanpur

Founder & Chief Radiologist – American Board of Radiology

Dr. Anurita Menon

Senior Scientific Officer

Frequently Asked Questions

What does an imaging core lab do in an oncology clinical trial?

An imaging core lab supports the standardized management, quality review, and interpretation of medical images used as clinical trial endpoints. In oncology trials, this typically includes standardized tumor response assessment across participating sites, using criteria such as RECIST 1.1, iRECIST, RANO, LUGANO, or other disease-specific criteria.

When does an oncology clinical trial need an imaging core lab?

An imaging core lab can be particularly important when imaging is used to determine tumor response or progression as a trial endpoint, especially in multicenter or global studies. Centralized review can help sponsors standardize image assessment across sites, maintain consistency between timepoints, manage independent or adjudicated reads, and establish an auditable process for endpoint assessment.

What is blinded independent central review (BICR)?

Blinded independent central review (BICR) is a centralized imaging review process in which qualified reviewers independently assess trial images without access to information that could influence their assessment, according to the trial protocol. Depending on the study design, BICR may involve independent dual reads and adjudication to resolve discrepancies. This approach helps support consistent, unbiased assessment of imaging-based clinical trial endpoints.

Does Image Core Lab apply RECIST 1.1 and other oncology response criteria?

Yes. Image Core Lab applies RECIST 1.1, iRECIST, and other protocol-defined and disease-specific response criteria across oncology clinical trials. Its reviewer teams are trained on irRC for solid tumors, LUGANO for lymphoma, IMWG for multiple myeloma, RANO for neuro-oncology (glioma), iwCLL for chronic lymphocytic leukemia, and mRECIST for liver. ICL’s radiologists have applied these response assessment methodologies across 25+ oncology projects.

How does Image Core Lab ensure consistency across readers and trial sites?

Image Core Lab ensures consistency through subspecialist radiologists, imaging quality oversight, standardized workflows, and adjudication. Single- and double-reviewer workflows blinded independent review, configurable QC, and CLINSpa’s audit trails further support standardized and traceable imaging assessments.

Trusted Core Lab Partner
For Oncology Clinical Trials