Intrinsic Imaging Undergoes Extensive FDA BIMO Inspection - Receives Zero 483 Observations
The FDA inspector highly praised Intrinsic Imaging's quality management system. In particular, the inspector highlighted the robustness of Intrinsic Imaging's quality control process to ensure the accurate data transfer of independent reviewer assessments to the sponsor.
BOSTON, Feb. 26, 2019 /PRNewswire-PRWeb/ -- Intrinsic Imaging, a global medical imaging core lab for clinical trials, announces today that it recently underwent an extensive 5-day high priority Bioresearch Monitoring Program (BIMO) inspection by the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER). This most recent inspection was related to a pivotal study of a new biologic license application (BLA) in patients with advanced epithelial cancers, including breast, glioblastoma multiforme, hepatocellular, lung, ovarian, prostate, and related cancers.
Similar to its prior inspections, Intrinsic Imaging was in complete compliance and received zero 483 observations from the FDA. During this successful inspection, the FDA audit included a review of all clinical trial documentation, standard operating procedures, site training and qualification records, image transmittal forms, radiologist RECIST determinations, case report forms, and adjudication determinations.
At the conclusion of the inspection, the FDA inspector highly praised Intrinsic Imaging's quality management system. In particular, the inspector highlighted the robustness of their quality control process to ensure the accurate data transfer of independent reviewer assessments to the sponsor.
"Intrinsic Imaging's quality management system is the most comprehensive and sophisticated in the industry." said Todd Joron, BSc, MBA, President & COO at Intrinsic Imaging. "Certified by the British Standards Institute (BSI), we are 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
"Whether it be our robust site qualification and training, our seamless image transfer and 24-hour quality control, or our reviewer selection and training on assessment criteria, our ISO certified process differentiates ourselves from all others in the industry." said Bryan Wayne, BSc, MBA, Vice President of Operations.
Jim Warpula, BSc., Vice President of Quality Assurance and Compliance added "We are very proud of the outcome of this recent FDA inspection. It is a testament of our excellence in providing quality results to sponsors at every stage."
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 500 full time and consulting board-certified, fellowship-trained physicians and key opinion leaders (KOLs). Intrinsic Imaging's team has sub-specialization in all therapeutic areas including cardiovascular, metabolic and pulmonary, gastrointestinal and genitourinary, medical device, musculoskeletal, neurology and oncology. 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.
SOURCE Intrinsic Imaging
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