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

Share Article

Intrinsic’s Imaging has implemented an ISO 9001:2008 compliant quality management system throughout the organization for all of its clinical trial services across all therapeutic areas and imaging modalities. 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.

When you combine the experience of our radiologists with our robust clinical imaging technologies & our ISO compliant quality imaging services, Intrinsic Imaging is a very valuable & effective imaging partner. Said Todd A. Joron, BSc, MBA, President & COO

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
Located in San Antonio, TX and Boston, MA, Intrinsic a leading imaging clinical research organization (CRO) providing complete image management and radiological review services to global pharmaceutical, biotechnology and medical device organizations. With its team of more than sixty sub-specialized, board-certified radiologists, its global imaging center consortium, and through its use of advanced medical imaging technology, Intrinsic’s experienced clinical trial team provides pharmaceutical and biotech sponsors with comprehensive imaging core lab services across all therapeutic areas. For more information, please visit http://www.IntrinsicCRO.com.

###

Share article on social media or email:

View article via:

Pdf Print

Contact Author

Todd Joron
Intrinsic Imaging LLC
1-888-492-9319 ext. 101
Email >
Visit website