Medical Imaging Core Lab
Intrinsic Imaging - A World Leader in Imaging Core Lab Services.
Founded in 2010, Intrinsic Imaging is a full-service medical 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, Cardiology, Central Nervous System, Gastroenterology, Musculoskeletal and Ophthalmology.
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 SystemArtificial 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.
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 Device or AI Algorithm to Market
510(k), De Novo & PMA
Imaging endpoint support for Class I, II and III 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.
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.
Ready to discuss your next trial?
Our team will respond within one business day.
3 FDA inspections
Zero 483 observations
5 BSI ISO certifications
9001, 13485, 22301, 27001, 27018
1000+ physicians
Board-certified, fellowship-trained