Digital management and regulatory submission of medical images from clinical trials: role and benefits of the core laboratory

William L. Robbins; James J. Conklin

doi:10.1117/12.225320

27 October 1995 Digital management and regulatory submission of medical images from clinical trials: role and benefits of the core laboratory

William L. Robbins, James J. Conklin

Author Affiliations +

Proceedings Volume 2499, Health Care Technology Policy II: The Role of Technology in the Cost of Health Care: Providing the Solutions; (1995) https://doi.org/10.1117/12.225320
Event: Health Care Technology Policy II: The Role of Technology in the Cost of Health Care: Providing the Solutions, 1995, Arlington, VA, United States

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.

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William L. Robbins and James J. Conklin "Digital management and regulatory submission of medical images from clinical trials: role and benefits of the core laboratory", Proc. SPIE 2499, Health Care Technology Policy II: The Role of Technology in the Cost of Health Care: Providing the Solutions, (27 October 1995); https://doi.org/10.1117/12.225320

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