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March 14, 2011

Intrinsic Imaging's Quality Management System Attains ISO 9001:2008 Compliance

Intrinsic Imaging's quality management system meets ISO 9001:2008 requirements across all clinical trial services, therapeutic areas and imaging modalities.

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Boston, MA and San Antonio, TX, March 14, 2011 — Intrinsic Imaging LLC, a leading imaging clinical research organization (CRO) providing complete image management and radiological review services to global pharmaceutical, biotechnology and medical device organizations, announces today its quality management system has attained International Organization for Standardization (ISO) 9001:2008 requirements compliance.

Intrinsic Imaging's compliance with ISO 9001:2008 requirements demonstrates that it has established, documented, implemented and currently maintains a compliant quality management system and that it continually improves its effectiveness in accordance with the requirements of the ISO 9001:2008 international standard.

Further, Intrinsic's compliance demonstrates its ability to consistently provide extensive imaging core lab services that meet customer and applicable statutory and regulatory requirements such as those required by clinical trial sponsors, the United States Food and Drug Administration as well as other global regulatory agencies.

Intrinsic's compliant quality management system has been implemented throughout the organization for all of its clinical trial services across all therapeutic areas and imaging modalities. Intrinsic Imaging's services include, but are not limited to:

  • expert radiologist consultations
  • protocol design and image charter development
  • investigator site qualification and training
  • complete imaging trial management
  • comprehensive imaging core lab services
  • image acquisition & processing
  • expert radiological image analysis and adjudication, and
  • data management & statistical analysis.

Within Intrinsic's quality management system, the company has identified key quality objectives which are measured regularly. As a testament to the Company's commitment to setting new standards in medical imaging core lab efficiency and quality, Intrinsic has formally incorporated its Metrics Champion Consortium (MCC) imaging performance targets into the quality objectives of its quality management system.

"We are very pleased our quality management system has attained ISO 9001:2008 compliance. When you combine the experience of our more than sixty sub-specialized, board-certified radiologists with our robust clinical imaging technologies and our ISO compliant quality imaging services, Intrinsic Imaging is a very valuable and effective imaging partner," said Todd A. Joron, BSc, MBA, President & Chief Operating Officer at Intrinsic Imaging.

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. Intrinsic Imaging is also a world leader in conducting Artificial Intelligence studies. With its team of more than 750 board-certified and fellowship-trained physicians, Intrinsic Imaging’s team has sub-specialization in all therapeutic areas, including Cardiovascular, Central Nervous System, Gastroenterology, Musculoskeletal, Oncology and Ophthalmology. Certified by the British Standards Institution (BSI), Intrinsic Imaging is the only company in the world to hold five ISO certifications specifically for providing imaging core lab services on clinical trials. For more information, please visit www.IntrinsicImaging.com.

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