Clinical Trial Sponsors Agree Intrinsic Imaging Core Lab Provides Exceptional Quality
Bolton (MA), San Antonio (TX) March 17, 2016
Intrinsic Imaging, an FDA audited, ISO 9001, 13485 and 22301 certified, GAMP® 5 compliant medical imaging core lab specializing in providing services for pharmaceutical and medical device clinical trials, today announced that for the calendar period ending December 31st, 2015, the Company attained exceptional quality results in its annual customer satisfaction survey.
Intrinsic Imaging offers Sponsors a wealth of therapeutic and operational expertise in support of clinical trials for new drug applications and medical devices. Each year they request Sponsors to evaluate Intrinsic Imaging’s performance in providing imaging core lab services.
For each clinical trial, Sponsors evaluate Intrinsic’s performance in sixteen areas grouped into four key categories. For the calendar year ending December 31st, 2015, Intrinsic Imaging’s Sponsors, which include a range of both small and large biotechnology, pharmaceutical, medical device and contract research organizations, unanimously reported that Intrinsic Imaging provides exceptional quality in every aspect of its business.
“Certified by the British Standards Institute, Intrinsic Imaging’s Quality Management System has the most extensive ISO certification portfolio in the industry,” said Todd A. Joron, BSc., MBA, President and Chief Operating Officer. “These results demonstrate our ability to provide imaging core lab services that consistently meet both customer and regulatory requirements.”
More specifically, in the key area of Operational Excellence, Sponsors recognized the effectiveness of Intrinsic Imaging’s ISO certified quality management system and rated Intrinsic Imaging as exceptional in project management (97%), quality of their radiology guidance (94%), effectiveness of their communications (92%) and consistency in meeting expectations (91%).
In the critical area of Quality, Sponsors rated Intrinsic Imaging exceptional in their ability to deliver quality data on time and on budget (96%), regulatory affairs expertise (95%), overall quality of service (94%) and their passionate commitment to quality (93%).
In their evaluation of Intrinsic Imaging’s clinical trial team, Sponsors scored Intrinsic as exceptional in flexibility (95%), attentiveness and responsiveness (94%), qualifications and experience (94%) and overall understanding of study requirements (93.4%).
Finally, in the area of contracts and agreements, Sponsors consistently rated Intrinsic’ s price competitiveness (97%), proposal clarity (96%), implementation of contracts (95%) and invoicing (92%) as exceptional.
About Intrinsic Imaging
Located in Bolton, Massachusetts and San Antonio, Texas, Intrinsic Imaging is an FDA audited, ISO 9001:2008 and ISO 13485:2003 certified, GAMP® 5 compliant medical imaging core lab specializing in providing imaging core lab services for clinical trials. Its comprehensive medical imaging core lab services include, but are not limited to, expert radiologist consultation, protocol and charter development, site qualification, training and management, as well as image acquisition, processing and detailed radiologic analysis.
Intrinsic Imaging has more than sixty full-time, board-certified diagnostic radiologists on staff that have sub-specialization in all therapeutic areas including, but not limited to, Cardiovascular, Central Nervous System, Gastrointestinal & Genitourinary, Medical Device, Musculoskeletal and Oncology.