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Proceedings Paper

Digital management and regulatory submission of medical images from clinical trials: role and benefits of the core laboratory
Author(s): William L. Robbins; James J. Conklin
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Paper Abstract

Medical images (angiography, CT, MRI, nuclear medicine, ultrasound, x ray) play an increasingly important role in the clinical development and regulatory review process for pharmaceuticals and medical devices. Since medical images are increasingly acquired and archived digitally, or are readily digitized from film, they can be visualized, processed and analyzed in a variety of ways using digital image processing and display technology. Moreover, with image-based data management and data visualization tools, medical images can be electronically organized and submitted to the U.S. Food and Drug Administration (FDA) for review. The collection, processing, analysis, archival, and submission of medical images in a digital format versus an analog (film-based) format presents both challenges and opportunities for the clinical and regulatory information management specialist. The medical imaging 'core laboratory' is an important resource for clinical trials and regulatory submissions involving medical imaging data. Use of digital imaging technology within a core laboratory can increase efficiency and decrease overall costs in the image data management and regulatory review process.

Paper Details

Date Published: 27 October 1995
PDF: 7 pages
Proc. SPIE 2499, Health Care Technology Policy II: The Role of Technology in the Cost of Health Care: Providing the Solutions, (27 October 1995); doi: 10.1117/12.225320
Show Author Affiliations
William L. Robbins, Bio-Imaging Technologies, Inc. (United States)
James J. Conklin, Bio-Imaging Technologies, Inc. (United States)

Published in SPIE Proceedings Vol. 2499:
Health Care Technology Policy II: The Role of Technology in the Cost of Health Care: Providing the Solutions
Warren S. Grundfest M.D., Editor(s)

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