ABOUT US
Our Story
Intrinsic Imaging was founded in 2010 by radiologists who had spent their careers interpreting millions of images and executives who had built imaging core labs for the world’s largest CROs. They shared a conviction that the imaging evidence behind a new drug or device should be read by subspecialty experts, managed with disciplined process and defensible to any regulator.
Over sixteen years, that conviction has carried Intrinsic Imaging from a founding team in San Antonio, Texas and Boston, Massachusetts to a global imaging core lab and imaging CRO whose work has supported FDA approvals and clearances across oncology, neurology, cardiology, medical devices and artificial intelligence.
This is Our Story.
2010: Radiologists Launch a Different Kind of Core Lab
On July 1, 2010, a group of clinical trial professionals and radiologists from South Texas Radiology Group, one of the nation's leading private radiology practices, launched Intrinsic Imaging LLC in San Antonio, Texas. The founding team paired more than 60 board-certified, subspecialized radiologists, who had overseen millions of images across fifteen imaging centers and more than a dozen hospitals, with executives who had spent decades building imaging core labs and eClinical technology inside the world's largest CROs.
The premise was that deep radiology expertise, modern technology and disciplined operations could redefine how imaging is managed in clinical trials. Within weeks of launch we became the first company to implement Merge Healthcare's Clinical Imaging Management System, and that September we published imaging performance targets against the Metrics Champion Consortium benchmarks that were 60 to 90 percent faster than the industry standard, backed by service level agreements for every sponsor.
2011 to 2012: Building the Quality Foundation
Our first full year brought our first major awards, including a pivotal multi-center trial in acute ischemic stroke, a five-year metastatic colorectal cancer program spanning more than 40 investigator sites, a multinational Phase II metastatic breast cancer trial and our first neurointerventional medical device study.
Just as importantly, we built the quality management system that would define us. Our QMS attained ISO 9001 compliance in March 2011 and was certified by the British Standards Institution (BSI) that November. In March 2012 we implemented ISPE GAMP 5 for compliant GxP computerized systems. That same month our neuroradiology team's work contributed to FDA clearance of a neurointerventional device for acute ischemic stroke. And in August 2012, following a five-day pre-approval inspection tied to a Phase III breast cancer trial in which we processed more than 4,300 images and case report forms, the FDA found Intrinsic Imaging in complete compliance and issued zero Form 483 observations. BSI awarded our ISO 13485 medical device certification the following month.
2013 to 2014: A New Home and a Broader Mandate
In February 2013 we opened our ISO-certified imaging campus in Bolton, Massachusetts, in Greater Boston, and centralized management of all national and international trials there. Trial awards grew in scale and ambition: an international Phase III trial in severe traumatic brain injury with more than 1,000 patients at over 100 sites, a five-year international Phase II iron overload program with more than 4,500 MRI scans, a global hepatocellular carcinoma trial using DCE-MRI, and landmark device trials in venous outflow obstruction, lung cancer, vascular and genitourinary indications.
In September 2013 our core lab expertise contributed to FDA premarket approval of a Class III device for breast cancer diagnosis, and a BSI audit of our QMS closed with zero observations. In March 2014 we added ISO 22301 Business Continuity certification, protecting sponsors' trials from disruption, and by September we had expanded our Medical Imaging Consultancy to more than 65 full-time, board-certified, fellowship-trained radiologists.
2015 to 2016: Sponsors Confirm the Model Works
As our portfolio expanded into glioblastoma, squamous cell carcinoma, pulmonary emboli prevention, percutaneous tumor ablation and a pivotal Phase III metastatic breast cancer trial, our sponsors told us how we were doing. In our 2014 customer satisfaction survey, sponsors rated our attentiveness and responsiveness at 97 percent and our understanding of study requirements at 94 percent. In 2015 they rated project management at 97 percent, on-time, on-budget delivery of quality data at 96 percent and price competitiveness at 97 percent.
In 2016 we shared what we had learned about ISO-certified quality management at Imaging in Clinical Trials in Philadelphia and at ASCO in Chicago, while our team grew to 70 full-time radiologists supporting large international Phase III oncology trials and Class III device studies.
2017 to 2018: Becoming the World Leader in AI Validation
Artificial intelligence began to transform radiology, and sponsors needed a core lab that could rigorously validate it. We had been running multiple-reader multiple-case (MRMC) studies for computer-aided detection software for years, and in 2017 the pace accelerated. We were awarded our tenth CAD/AI/deep learning trial in August 2017, our twelfth that September and our fifteenth in January 2018, each supporting an FDA submission and often involving more than 14,000 radiology reviews drawn from a network of more than 200 reviewers.
In March 2017 we added ISO 27001 Information Security certification, and today we remain the only imaging core lab in the world to hold five ISO certifications from BSI specifically for imaging core lab services. In March 2018 we completed a 12,480-read pivotal oncology trial with 24 radiologists in five weeks, on time and on budget. In June 2018 the results of our pivotal MRMC study of concurrent CAD for digital breast tomosynthesis were published in the American Journal of Roentgenology, with our own Dr. Richard Benedikt as lead author.
2019 to 2021: Three FDA Inspections, Zero Observations
In February 2019 the FDA's Center for Drug Evaluation and Research conducted a five-day, high-priority BIMO inspection related to a pivotal biologic license application in advanced epithelial cancers. We received zero 483 observations, and the inspector specifically praised the robustness of our quality control process for transferring independent reviewer assessments to the sponsor. In March 2021 a third FDA inspection, tied to a pivotal metastatic cancer drug, again closed with no findings.
In July 2021, WCG acquired Intrinsic Imaging for $80 million, citing our commitment to quality and our ISO-certified QMS as key drivers of the decision. As WCG Intrinsic Imaging, we retained our leadership and our Bolton headquarters, and used WCG's scale to extend the global reach of our imaging operations across more than 500 physicians.
2026: Independent Again, and Looking Ahead
On September 1, 2026, after five years within WCG, Intrinsic Imaging returned to independent, management-led ownership. Today our network includes more than 750 board-certified, fellowship-trained physicians supporting over 4,000 imaging centers in 64 countries, with subspecialty expertise across oncology, cardiology, central nervous system, gastroenterology, musculoskeletal and ophthalmology indications, and we remain a recognized leader in validation studies for AI, CAD and advanced imaging software.
Independence restores the agility to invest decisively in our technology platform, our global physician network and our AI expertise. Our objective is unchanged from the day we opened our doors: to reduce imaging complexity, protect the integrity of clinical trial endpoints, and help bring important therapies and medical technologies to patients.
Milestones
2010
Intrinsic Imaging founded in San Antonio by radiologists and clinical trial executives; first to implement Merge CIMS; publishes Metrics Champion Consortium performance targets
2011
First pivotal trial awards (acute ischemic stroke, metastatic colorectal and breast cancer, neurointerventional device); ISO 9001 certification by BSI
2012
ISPE GAMP 5 implemented; core lab expertise contributes to FDA clearance of a stroke device; first FDA inspection, zero 483 observations; ISO 13485 certification
2013
Greater Boston campus opens in Bolton, MA; core lab expertise contributes to FDA premarket approval of a Class III breast cancer device; BSI audit with zero observations
2014
ISO 22301 Business Continuity certification; consultancy expands to 65+ full-time radiologists
2015
Sponsors rate project management, quality and responsiveness in the 90s in annual satisfaction surveys
2016
Team grows to 70 full-time radiologists
2017
ISO 27001 Information Security certification; tenth and twelfth CAD/AI/DL MRMC trials awarded
2018
Fifteenth AI trial awarded; 12,480-read pivotal oncology trial completed in five weeks; pivotal AI study published in AJR
2019
Second FDA inspection (BIMO, CDER), zero 483 observations
2021
Third FDA inspection, zero 483 observations; acquired by WCG for $80 million
2026
Returns to independent ownership; 750+ physicians, 4,000+ imaging centers, 64 countries