Imaging CRO
A full-service medical imaging CRO and imaging core lab for global clinical trials.
Founded in 2010, Intrinsic Imaging is a full-service medical imaging CRO and core lab providing comprehensive services in support of Phase I–IV clinical trials and Class I, II, III medical device trials. Intrinsic Imaging is also a world leader in conducting Artificial Intelligence / CAD studies.
With its team of more than 1,000 board-certified and fellowship-trained physicians and a network of over 4,000 imaging centers in 64 countries, Intrinsic Imaging's team has sub-specialization in all therapeutic areas, including Oncology, Cardiology, Central Nervous System, Gastroenterology, Musculoskeletal and Ophthalmology.
Services
End-to-end imaging CRO services.
Our team supports sponsors with 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 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 sub-specialty experts.
Biostatistics & Data Management
Statistical analysis plans, adjudication workflows, and 21 CFR Part 11 compliant data delivery.
Medical Device Trials
Imaging endpoint support for Class I, II, and III 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 successfully completed three FDA Bioresearch Monitoring Program inspections spanning both medical device and pharmaceutical clinical trials, with each inspection concluding with zero Form FDA 483 observations. This consistent regulatory performance demonstrates the strength and effectiveness of our Quality Management System, operational controls, documentation practices, and commitment to data integrity.
Certified by the British Standards Institution (BSI), Intrinsic Imaging is the only imaging core lab in the world to hold five ISO certifications specifically for the provision of imaging core lab services for clinical trials. Together, these internationally recognized standards provide an integrated framework governing the processes, technologies, personnel, data, and controls that support Phase I–IV pharmaceutical and biotechnology trials, Class I–III medical device studies, and complex artificial intelligence and medical imaging software validation programs.
This disciplined approach provides sponsors with a quality infrastructure designed to reduce operational and regulatory risk, protect the integrity of imaging endpoints, and produce 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.
Tell us about your trial.
We'll scope imaging CRO services tailored to your endpoints and timeline.