Intrinsic Imaging, a full-service medical imaging core lab for clinical trials, announces today that it recently underwent an extensive Bioresearch Monitoring Program (BIMO) inspection by the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER). This inspection was related to a pivotal study of a novel drug to treat patients with metastatic cancer.
The FDA determined Intrinsic Imaging was in complete compliance with all federal regulations and the company received zero 483 observations.
This was Intrinsic Imaging’s third FDA inspection and its third inspection with no findings.
During this successful inspection, the FDA audited Intrinsic Imaging’s ISO certified quality management system, standard operating procedures, systems validation, clinical trial documentation, as well as case quality control and primary reviewer and adjudication assessments.
“Our quality management system is one of the most comprehensive and sophisticated in the industry,” said Todd A. Joron, BSc, MBA, President & COO at Intrinsic Imaging. “This successful audit bears testament to our continued commitment to quality.”
Certified by the British Standards Institute (BSI), Intrinsic Imaging is the only company in the world to hold five ISO certifications specifically for providing imaging core lab services on clinical trials. Intrinsic Imaging’s quality management system is certified to the following standards:
- ISO 9001 – Quality Management Systems for Phase I-IV clinical trials
- ISO 13485 – Quality Management Systems for Class I-III medical device trials
- ISO 22301 – Business Continuity Management System
- ISO 27001 – Informational Security Management System
- ISO 27018 – Protection of Personally Identifiable Information on the Cloud
“We are very pleased with the results of this most recent FDA inspection and we look forward to continuing to provide quality services to all of our clinical trial Sponsors.” said Bryan Wayne, Vice President, Imaging Operations at Intrinsic Imaging.
About Intrinsic Imaging, LLC
Intrinsic Imaging is a full-service medical imaging core lab providing comprehensive services in support of Phase I-IV clinical trials and Class I, II, III medical device trials. Its team consists of more than 600 board-certified and fellowship-trained physicians. Intrinsic Imaging’s team has sub-specialization in all therapeutic areas including cardiology, central nervous system, gastroenterology, musculoskeletal, oncology and ophthalmology. Certified by the British Standards Institute (BSI), Intrinsic Imaging is the only company in the world to hold five ISO certifications specifically for providing imaging core lab services on clinical trials. With our medical expertise, operational excellence and ISO-certified quality management systems, Intrinsic Imaging is ideally positioned to provide imaging core lab services to clients worldwide.