Intrinsic Imaging Awarded International Phase III Clinical Trial for Novel Orthopedic Medical Device
Bolton, MA, San Antonio, TX (PRWEB) September 18, 2012
Intrinsic Imaging, an FDA audited, ISO 9001:2008 certified and GAMP 5® medical imaging core lab specializing in providing imaging core lab services for clinical trials, announces today that it was recently awarded an international Phase III clinical trial for the assessment of a novel orthopedic medical device.
This multicenter clinical trial consists of over 400 patients and approximately 7,000 computed tomography (CT) scans, magnetic resonance (MRI) scans and conventional radiographs. During this trial, Intrinsic Imaging will provide imaging core lab services including, but not limited to, the acquisition of the images from the investigator sites, quality control, and the complex quantitative and qualitative orthopedic assessment of the images to determine the medical device’s safety and effectiveness.
Intrinsic Imaging’s team of more than sixty board-certified diagnostic radiologists possesses sub-specialization in all therapeutic areas. The Intrinsic Imaging orthopedic radiologists dedicated to this trial have extensive experience in supporting Sponsors conducting orthopedic clinical research in joint reconstruction hardware, spinal fusion and spinal motion preserving devices, novel biologics ranging from articular and fibrocartilage repair as well as tendon and ligament regrowth and reconstruction.
“Imaging provides an abundance of qualitative and quantitative data useful in the evidence based assessment of new orthopedic interventions and devices. As investigational devices are often novel, an intimate understanding of all aspects of the device including engineering, material composition, surgical placement technique, and device positioning are important in the design of imaging protocols tailored to assess the success or failure of such device.” said Dr. Jack Clement, Medical Director of Musculoskeletal Radiology at Intrinsic Imaging. “Intrinsic Imaging’s radiologists are experts in the complex quantitative and qualitative orthopedic assessments to determine efficacy, safety, and longevity of these orthopedic advancements.”
As novel orthopedic devices enter clinical evaluation, the selection of imaging modalities, acquisition parameters and analysis tools must be tailored to the needs of the trial. Each modality provides different, but complementary qualitative and quantitative data. Advancements in CT and MRI techniques afford these modalities a greater role in precise evaluation of orthopedic devices. Additionally, the use of traditional radiography is enhanced by the application of software evaluation techniques, especially in the case of spinal motion analysis.
“Intrinsic Imaging’s orthopedic medical device expertise includes dynamic and static evaluations of the full complement of joint and spine disorders and diseases.” said Todd A. Joron, BSc. MBA, President and Chief Operating Officer, Intrinsic Imaging. “We are very pleased to contribute our operational and therapeutic expertise towards this international Phase III clinical trial for the assessment of this novel orthopedic medical device.”
About Intrinsic Imaging LLC
Located in Bolton, Massachusetts and San Antonio, Texas, Intrinsic Imaging is an FDA audited, ISO 9001, ISO 13485, ISO 22301 and ISO 27001 certified and GAMP5 compliant medical imaging core lab specializing in providing imaging core lab services for clinical trials. With its team of more than seventy board-certified fellowship trained radiologists, robust and scalable clinical imaging technologies and its ISO certified quality management systems, Intrinsic Imaging is ideally positioned to provide unprecedented imaging core lab services around the world.