Intrinsic Imaging

Imaging CRO

ISO Certified Imaging CRO

Founded in 2010, Intrinsic Imaging is a full-service imaging CRO for Phase I-IV clinical trials and Class I, II and III medical device trials, built on an ISO certified imaging core lab. We support every step — from imaging charter development and site qualification through blinded independent central review (BICR) and regulatory-ready data delivery. Intrinsic Imaging is also a world leader in Artificial Intelligence / CAD studies.

Our team includes more than 750 board-certified and fellowship-trained physicians. Our network spans over 4000 imaging centers in 64 countries. We subspecialize in all therapeutic areas, including Oncology, Cardiovascular, Central Nervous System, Gastroenterology, Musculoskeletal and Ophthalmology.

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Radiologist reviewing clinical trial imaging in an imaging CRO reading room

Services

End-to-end imaging CRO services.

Our team supports sponsors at every step: imaging protocol and charter development, site qualification and training, centralized image collection and quality control, blinded independent image review, endpoint adjudication, and quantitative image analysis. We work across a broad range of imaging modalities and therapeutic areas.

Protocol & Charter Design

Imaging protocol development, charter authoring, and endpoint definition aligned to regulatory expectations.

Site Qualification & Training

Equipment surveys, scanner validation, technologist training, and site certification across global networks.

Image Acquisition Standardization

Acquisition guidelines, phantom QC, and ongoing site monitoring to ensure data consistency across sites.

Independent Central Reads

Blinded independent reviews with single, double, and triple-read paradigms by subspecialty experts.

Imaging Data Management

Imaging data reconciliation, adjudication workflows, and 21 CFR Part 11 compliant data delivery.

Medical Device Trials

Imaging endpoint support for Class I, II, and III medical device trials, including 510(k), De Novo, and PMA submissions.

Phase I–IV Clinical Trials

End-to-end imaging support from first-in-human through post-market, across all therapeutic areas.

Regulatory Submission Support

FDA, EMA, PMDA submission packages with audit-ready documentation and traceability.

Quality Management System

ISO Certified by BSI. Inspected by the FDA.

Intrinsic Imaging has completed three FDA Bioresearch Monitoring Program inspections. They covered both medical device and pharmaceutical clinical trials. Each inspection closed with zero Form FDA 483 observations. This record shows the strength of our Quality Management System, our operational controls, our documentation practices, and our commitment to data integrity.

Intrinsic Imaging is certified by the British Standards Institution (BSI). We are the only imaging core lab in the world to hold five ISO certifications specifically for imaging core lab services for clinical trials. Together, these standards form one integrated framework. It governs the processes, technologies, personnel, data, and controls behind:

  • Phase I–IV pharmaceutical and biotechnology trials
  • Class I–III medical device studies
  • Complex artificial intelligence and medical imaging software validation programs

This disciplined approach gives sponsors a quality infrastructure built to reduce operational and regulatory risk. It protects the integrity of imaging endpoints. And it produces reliable, audit-ready evidence for some of the world's most complex clinical development programs.

FDA Inspected — a record of regulatory excellence.

ISO Certified — a foundation of quality and trust.

How a trial runs with us

How a Trial Runs With Us

Stage 1: Protocol & Imaging Charter

We author the imaging charter and acquisition guidelines, define endpoints and response criteria, and align the read design with regulatory expectations before the first subject is scanned.

  • Protocol & Imaging Charter: We author the imaging charter and acquisition guidelines, define endpoints and response criteria, and align the read design with regulatory expectations before the first subject is scanned.
  • Site Qualification & Training: Equipment surveys, scanner validation, phantom QC and technologist training standardize acquisition across every participating imaging center.
  • Image Transfer & Quality Control: Sites upload images securely. Each exam is de-identified and checked against the protocol, and queries are raised with the site quickly.
  • Blinded Independent Central Review: Subspecialty readers perform blinded single, double or triple reads, with adjudication when readers disagree, plus quantitative analysis where required.
  • Data Delivery & Regulatory Support: Validated imaging data transfers, central-review datasets and audit-ready documentation support your submission and any inspection that follows.

For the full six-step core lab process with turnaround expectations, see our imaging core lab.

An Imaging CRO Built Around Your Evidence Requirements

An imaging CRO coordinates the scientific and operational work needed to turn multicenter images into trial evidence. Intrinsic Imaging brings acquisition, subspecialty review, quantitative analysis and quality oversight into a study-specific delivery model.

Anatomic, Functional and Molecular Imaging

We support CT and MRI morphology, PET and SPECT molecular imaging, cardiac ultrasound, angiography, bone-density imaging, retinal imaging and central endoscopy assessment. Advanced workflows include diffusion and perfusion MRI, volumetry, liver fat and stiffness, quantitative PET and radiomics. The selected methods reflect the protocol and the validation needed for each endpoint.

Primary, Secondary, Safety and Exploratory Endpoints

We help sponsors define how an imaging biomarker will be used and what controls it needs. A primary endpoint may demand a different review design and validation package from an exploratory radiomics analysis. We align the imaging charter and operational plan with the protocol’s imaging requirements before study execution so acquisition and interpretation support the intended evidence question.

Working With Sponsors and Their Clinical CROs

We agree interfaces with the sponsor’s clinical operations, data management and medical monitoring teams. A responsibility matrix defines site communication, query ownership, safety escalation and data transfers. Full-service and targeted engagements use the same principle: clear ownership of each step, with documented handoffs and an agreed closeout package.

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

Endpoints we read

Modalities & Response Criteria Matrix

We support established and protocol-specific criteria. Imaging, endoscopy, tissue and functional assessments use distinct methods selected for your endpoints.

Therapeutic areaModalitiesResponse criteria & endpoints
OncologyCT, MRI, PET/CT, bone scan
RECIST 1.1iRECISTmRECISTRANOLuganoPCWG3PERCISTChoi
CardiovascularEchocardiography, cardiac MRI, CT angiography, IVUS
LVEFStrain imagingPlaque volumeValvular regurgitation grading
Central Nervous SystemMRI, amyloid & tau PET, DaT-SPECT, CT/CTA
MS lesion burdenVolumetric MRIHippocampal volumetryAmyloid/Tau PETARIA-E/ARIA-HASPECTS
MusculoskeletalX-ray, MRI, DXA, QCT
Sharp/van der HeijdeRAMRISMOAKSWORMSKellgren-LawrenceBone mineral density
GastroenterologyEndoscopy, MR enterography, MRI-PDFF, elastography; separate histopathology
SES-CDMayo endoscopic subscoreUCEISMaRIALiver fat/stiffnessRobarts Histopathology Index
OphthalmologyOCT, fundus photography, fluorescein angiography
Central subfield thicknessGeographic atrophy areaDR severity grading

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
750+
Supporting global trials
Since 2010

Direct physician access

Work Directly With Our Medical Leadership

  • • Your medical monitor talks directly to board-certified physicians — no intermediary layers.
  • • Physicians help author your imaging charter and resolve reader discrepancies.
  • • The same leadership team stays with your study from kickoff to database lock.
Meet Our Leadership

Featured Case Study

Intrinsic Imaging

Oncology

Fast-Track Rare Disease Oncology Trial

  • 40 sites in 14 countries
  • Fewer than 3 patients per site
  • Priority Review program

Challenge

Registration trials in rare diseases operate under unforgiving constraints. With fewer than three patients per site spread across 40 sites in 14 countries, every imaging timepoint carried outsized weight, and any delay in central review directly threatened enrollment momentum. The sponsor's Priority Review designation compressed timelines further, requiring a core lab capable of rapid startup and exceptionally responsive query handling without compromising the rigor of the imaging assessments.

Read the case study
View all case studies

Frequently Asked Questions

At what stage should an imaging CRO be engaged in study planning?
Ideally before the protocol and imaging schedule are finalized. Early review clarifies acquisition requirements, endpoint feasibility and central-reading dependencies. We can also assume responsibility for an active study through a controlled transfer.
Can Intrinsic Imaging collaborate with our clinical CRO?
Yes. A responsibility matrix agreed at startup defines site communication, query ownership, safety escalation and data transfers among the core lab, the sponsor and the clinical CRO.
Does Intrinsic Imaging support medical device and AI/CAD studies?
Yes. We support Class I–III medical device trials as well as stand-alone and multi-reader multi-case AI/CAD observer performance studies. Our services include controlled case handling, reader training, blinded assessments and traceable imaging evidence aligned with the medical device’s intended use and study protocol.
What is the difference between an imaging CRO and an imaging core lab?
The core lab provides blinded independent central review and imaging data delivery. The imaging CRO coordinates the broader scientific and operational work needed to turn multicenter images into trial evidence, including imaging protocol and charter development, site qualification and training, acquisition standardization, subspecialty review, quantitative analysis and quality oversight. Intrinsic Imaging provides both within a study-specific delivery model.
How does an imaging CRO work alongside a sponsor’s full-service CRO?
We agree interfaces with the sponsor’s clinical operations, data management and medical monitoring teams. A responsibility matrix defines site communication, query ownership, safety escalation and data transfers. Clear ownership of each step, documented handoffs and an agreed closeout package guide the engagement.
What imaging data and documentation does the imaging CRO deliver at study closeout?
The closeout package is agreed for each engagement. Deliverables include validated imaging data transfers, central-review datasets and audit-ready documentation, supported by imaging data reconciliation and adjudication workflows. These outputs support the sponsor’s regulatory submission and subsequent inspections.

Tell us about your trial.

We'll scope imaging CRO services tailored to your endpoints and timeline.

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  • 3 FDA inspections

    Zero 483 observations

  • 5 BSI ISO certifications

    9001, 13485, 22301, 27001, 27018

  • 750+ physicians

    Board-certified, fellowship-trained