Intrinsic Imaging

ISO Certified Imaging Core Lab

Intrinsic Imaging — Imaging CRO for Drug, Medical Device and AI Trials

Founded in 2010, Intrinsic Imaging is an ISO certified imaging core lab and imaging CRO providing comprehensive services in support of Phase I-IV clinical trials and Class I, II, III medical device trials — from imaging charter development and site qualification through blinded independent central review (BICR) and 21 CFR Part 11 compliant data delivery.

We turn imaging into reliable efficacy and safety endpoints, measuring imaging biomarkers consistently across sites, scanners, readers, and timepoints. Intrinsic Imaging is also a world leader in conducting Artificial Intelligence / CAD studies.

With our team of 1000+ board-certified and fellowship-trained physicians, Intrinsic Imaging has subspecialization in all therapeutic areas, including Oncology, Cardiovascular, Central Nervous System, Gastroenterology, Musculoskeletal and Ophthalmology.

Cardiologist reviewing 3D cardiac CT in a clinical trial reading room
Radiologist reviewing brain MRI scans in a clinical trial core lab

Quality Management System

ISO Certified by BSI. Inspected by the FDA.

Certified by the British Standards Institute (BSI), Intrinsic Imaging's quality management system is among the most comprehensive and sophisticated in the industry. Intrinsic Imaging is the only organization in the world to hold five International Organization for Standardization (ISO) certifications specifically for providing imaging core lab services for clinical trials. Our Quality Management System ensures the highest standards of accuracy, reliability, and regulatory compliance across every study we support.

Learn more about Intrinsic Imaging's Quality Management System
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AI/CAD Studies

Artificial Intelligence

A World Leader in MRMC AI/CAD Validation Studies

Intrinsic Imaging is the world leader in conducting stand-alone and multi-case multi-reader observer performance studies to evaluate Artificial Intelligence (AI) / CAD / Viewer software.

  • Experience and expertise conducting 55 large MRMC AI/CAD trials.
  • Routinely manages 10000–30000 case reviews.
  • Multiple FDA clearances of AI/CAD/Viewer devices – most in the industry.
  • ISO 13485 certification specifically for medical device clinical trials.
Explore our AI capabilities
Oncology PET/CT with AI tumor segmentation overlays

A Letter from Our CEO

“Our objective is not simply to compete in the imaging CRO industry. It is to redefine what the industry can achieve. We measure that by the confidence a sponsor places in a single image.”

Todd A. Joron, President & CEO

Read the full Letter from Our CEO

Imaging Capabilities Across the Clinical Development Program

Intrinsic Imaging connects subspecialty interpretation with quantitative imaging and controlled trial operations. Sponsors can combine anatomic, functional and molecular imaging within one coordinated core lab workstream.

From Scan Acquisition to Measurable Endpoints

Our capabilities span CT, MRI, PET/CT, SPECT, ultrasound, echocardiography, radiography, DXA, angiography, intravascular imaging, retinal imaging and central endoscopy review. We match each method to the indication, acquisition requirements and endpoint, rather than applying one reading model to every trial.

Imaging Biomarkers, Radiomics and Independent Evidence

We support tumor measurements, brain and tissue volumes, cardiac function, liver fat and stiffness, bone density and retinal structural measures. Quantitative imaging and radiomics workflows include segmentation review, method specification and reproducibility checks. Independent central review and adjudication connect those measurements to the protocol’s efficacy, safety and exploratory analyses.

Medical Device & AI Track

Bring Your Medical Device or AI Algorithm to Market

510(k), De Novo & PMA

Imaging endpoint support for Class I, II and III medical device trials, backed by ISO 13485 certification.

MRMC reader studies

Multi-reader multi-case design and execution for AI/CAD and SaMD — 55+ large MRMC studies completed.

Ground truth panels

Expert adjudication panels drawn from 1000+ board-certified physicians establish reference standards.

FDA inspection readiness

Zero 483 observations across our FDA inspections, including CDRH.

Medical Device Imaging division AI & CAD Validation

Global Site Network & Faster Study Startup

Startup delays are expensive. Our experience with thousands of imaging centers means many of your sites may already know our acquisition guidelines. Standardized scanner qualification and phantom QC work across all major scanner manufacturers, so new sites are qualified and trained quickly.

Imaging centers worked with
4000+
Countries
64
Board-Certified Physicians
1000+
Supporting global trials
Since 2010

Study Rescue & Core Lab Transfer

Is your current core lab missing read timelines or losing readers? We transfer image archives, harmonize your imaging charter and mobilize subspecialty readers so your trial keeps moving.

Rescue my study

Guidance for Sponsors

Physician-authored guidance from Intrinsic Imaging on imaging endpoints and trial design.

MRI image of the knee

Guidance for Sponsors · Volume 5, Issue 11 · 2026 Edition

Quantitative MRI Imaging in Orthopedic Clinical Trials

Orthopedic trials have long depended on patient questionnaires and on radiographic joint space width, a measurement of what cannot be seen. Quantitative MRI measures cartilage, bone and soft tissue directly, in three dimensions, and can reveal biochemical change before structural loss occurs. Validated scoring systems for rheumatoid arthritis, consensus profiles for compositional cartilage imaging and metal artifact reduction techniques for implants have made MRI a practical endpoint across arthritis and device trials. This issue reviews those methods and what sponsors must standardize to use them well.

Read the article
Illustration of a blood cancer cell

Guidance for Sponsors · Volume 5, Issue 10 · 2026 Edition

Medical Imaging of Chronic Lymphocytic Leukemia

Chronic lymphocytic leukemia has been transformed by targeted therapy. BTK inhibitors, BCL-2 inhibition and cellular therapies have pushed five-year survival above 90%, and in October 2026 FDA approved pirtobrutinib for previously untreated disease. Imaging plays a narrower but critical role in this disease: international guidelines do not require CT in routine practice, yet they consider it desirable in clinical trials, and FDG-PET/CT is the key tool for detecting Richter transformation. This issue sets out where imaging belongs in a CLL trial and how to standardize it.

Read the article
Illustration of an inflamed knee joint

Guidance for Sponsors · Volume 5, Issue 9 · 2026 Edition

Medical Imaging of Osteoarthritis of the Knee in Clinical Trials

Osteoarthritis of the knee is among the most common causes of disability, and among the most difficult conditions in which to prove that a therapy modifies disease. Radiographic joint space narrowing, the traditional structural endpoint, is slow, indirect and sensitive to positioning. MRI shows cartilage, bone marrow, menisci and synovium directly, and validated semiquantitative scores, quantitative cartilage morphometry and compositional mapping now offer far more sensitive measures of change. This issue reviews the strengths and limitations of each modality and how sponsors should combine them in trials of disease-modifying therapies.

Read the article
Browse all Guidance for Sponsors →

Frequently Asked Questions

Intrinsic Imaging is an ISO certified imaging core lab and imaging CRO. We support clinical trials from imaging protocol and charter development through site qualification, image quality control, blinded independent central review and final imaging data delivery.

We support Phase I–IV pharmaceutical and biotechnology trials, Class I–III medical device trials, and artificial intelligence and computer-aided detection studies. Imaging workflows are tailored to the study’s intended use, endpoints and regulatory requirements.

Our therapeutic expertise includes Oncology, Cardiovascular, Central Nervous System, Gastroenterology, Musculoskeletal and Ophthalmology. Subspecialty physicians assess imaging using the acquisition methods, response criteria and biomarkers specified for each study.

Intrinsic Imaging holds five BSI ISO certifications covering quality management, medical device quality management, business continuity, information security and protection of personally identifiable information in the cloud. We have also completed three FDA inspections, each with zero Form FDA 483 observations.

Yes. Our network spans 4000+ imaging centers in 64 countries, supported by 1000+ board-certified and fellowship-trained physicians. For ongoing studies, our study rescue services address image archive transfer, charter harmonization, reader mobilization and site re-engagement.

Ready to discuss your next trial?

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  • 3 FDA inspections

    Zero 483 observations

  • 5 BSI ISO certifications

    9001, 13485, 22301, 27001, 27018

  • 1000+ physicians

    Board-certified, fellowship-trained