BOSTON, Feb. 26, 2019 /PRNewswire-PRWeb/ -- Intrinsic Imaging, a global medical imaging core lab for clinical trials,
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;
"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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