Intrinsic Imaging Expands its Medical Imaging Consulting Group for Clinical Trials
Bolton, (MA), San Antonio, (TX) September 2, 2014
Intrinsic Imaging is an FDA audited, ISO 9001:2008 and ISO 13485:2003 certified, GAMP® 5 compliant imaging core lab, which provides Sponsors with quality imaging core lab services and comprehensive medical imaging consulting for their clinical trials.
Intrinsic Imaging’s Medical Imaging Consultancy offers Sponsors direct access to its subspecialty radiologists who are able to provide a wealth of therapeutic, operational expertise and guidance to best optimize the use of imaging in Phase I, II and III clinical trials in support of New Drug Applications, and in Class I, II and III Medical Device clinical trials in support of 510(k) clearances and Premarket Approvals (PMA).
In response to increased business demand, Intrinsic Imaging announces today that it has expanded its Medical Imaging Consultancy Group to more than 65 experienced full-time board-certified fellowship trained radiologists. Together, Intrinsic Imaging radiologists have sub-specialization in all therapeutic areas including, but not limited to Cardiovascular, Central Nervous System, Gastrointestinal, Genitourinary, Musculoskeletal, Oncology and Pulmonary.
With more than 20 state of the art imaging centers, Intrinsic Imaging’s 65 radiologists interpret more than 1 million images annually. Thereby in addition to therapeutic expertise, Intrinsic Imaging radiologists also have extensive experience in the utilization and application of the full spectrum of imaging technologies available. These include, but are not limited to, Computed Tomography (CT), Cardiac CT (CCT), Dual-energy x-ray absorptiometry (DXA), Digital and Conventional Radiography, Echocardiography (ECHO), Magnetic Resonance Imaging (MRI), including Dynamic contrast-enhanced (DCE-MRI), Single-Photon Emission Computerized Tomography (SPECT), Positron Emission Tomography (PET), PET-CT and Ultrasound.
Under the direction of Dr. Amit Mehta, Intrinsic Imaging’s Chief Medical Officer, Intrinsic Imaging’s Medical Imaging Consultancy Group is led by a very experienced senior team of medical directors who oversee each therapeutic area. These professionals include:
- Amit Mehta, M.D., Chief Medical Officer, Medical Device & Interventional Radiology Consulting
- Jack Clement, M.D., Ph.D., Medical Director, Musculoskeletal Imaging Consulting
- Neal Dalrymple, M.D., Medical Director, Gastrointestinal & Genitourinary Imaging Consulting
- James Dix, M.D., Medical Director, Neurological Imaging Consulting
- Michael Lane, M.D., Medical Director, Cardiovascular and Pulmonary Imaging Consulting
- Todd Tibbetts, M.D., Ph.D., Medical Director, Oncological Imaging Consulting
“Intrinsic Imaging’s Medical Imaging Consulting Group provides Sponsors with comprehensive medical imaging consulting in support of pharmaceutical, biotechnology and medical device clinical trials,” said Todd Joron, BSc., MBA, President and COO, Intrinsic Imaging. “With our team of more than sixty-five board-certified diagnostic radiologists, Intrinsic Imaging is ideally positioned to provide unprecedented imaging core lab and medical imaging consulting services to Sponsors.”
Intrinsic Imaging’s Medical Imaging Consulting Services for Clinical Trials includes;
- Direct access to board-certified subspecialty radiologists who are able to provide a wealth of therapeutic and operational expertise to best optimize the use of imaging in clinical trials
- ISO 9001 certified imaging guidance for Phase I, II and III Clinical trials in support of New Drug Applications
- ISO 13485 certified imaging guidance for Class I, II and III Clinical trials in support of Medical Device 510(k) clearances and Premarket Approvals (PMA)
- Enhanced study designs for Cardiovascular, Pulmonary, Central Nervous System, Gastrointestinal, Genitourinary, Medical Device, Musculoskeletal and Oncology studies
- In-depth guidance and recommendations on selection of the most appropriate imaging modalities and equipment across all vendor platforms
- Contribution to the Study Protocol to ensure greatest efficiencies
- Experienced advice and development of the Imaging Charter including blinded review and adjudication plan
- Development of the Imaging Acquisition Guide to provide investigator sites with the most favorable imaging scanning techniques
- Selection of optimal imaging endpoints for efficacy and / or safety endpoints
- Expert representation at regulatory meetings in support of new drug or device submissions
About Intrinsic Imaging, LLC
Located in Bolton, Massachusetts and San Antonio, Texas, Intrinsic Imaging is an FDA audited, ISO 9001:2008 and ISO 13485:2003 certified, GAMP® 5 medical imaging core lab specializing in providing imaging core lab services for clinical trials. With its team of more than sixty board-certified diagnostic radiologists, robust and scalable clinical imaging technologies and our ISO certified and registered quality management systems, Intrinsic Imaging is ideally positioned to provide unprecedented imaging core lab services around the world.