Imaging Service for Clinical Trials

A new medical imaging service for scanning and archiving medical images, including computed tomography (CT), magnetic resonance images (MRI), and x-rays, has just been implemented and validated to support clinical studies of two intervertabral disk devices under development by one of the world's largest medical device companies.

"We've made a significant investment in these technology solutions for managing data and medical images for clinical trials," said Richard Purcell, president of ClinPro, Inc. (Bound Brook, NJ, USA), developer of the imaging service. "The Scan Center and medical imaging systems have been developed in response to our long-term, strategic efforts in overall process improvement in clinical trial management. Moving forward, we plan to enhance the relationship we have with our business clients to utilize new technology solutions to optimize the clinical development process, resulting in greater savings in time, money, and resources.”

The new medical imaging service is an addition to ClinPro's existing Scan Center technology. The system creates digital imaging and communications in medicine (DICOM) files, which are electronically delivered to radiologists in several sites across the United States that use dedicated software to assess and report on the outcomes of various medical procedures. The "marked up” images are then electronically sent back to ClinPro for storage in a database and archived for future reference and submission to the U.S. Food and Drug Administration (FDA). All images can be viewed via the web by sponsors, staff, and consulting physicians using ClinPro's proprietary web-based project management system, ClinOps.

The spine studies also use ClinPro's Scan Center, which provides imaging and archiving services for storing electronic images of case report forms (CRFs), data clarification forms (DRFs), and clinical monitoring reports. The imaging system creates TIF-files that are automatically filed by patient, investigator, and/or page. In addition to archiving the documents, the system allows the images to be viewed online via the ClinOps or ClinPlus Remote systems.

Several other ongoing trials are utilizing the Scan Center for data management. Currently, an international clinical trial involving 80 sites in 18 countries is using the Scan Center, demonstrating that it is a powerful, comprehensive and flexible data management system designed for managing clinical trial data and allows for remote data capture and processing via fax or the web, and is flexible enough to handle conventional paper studies.

Using advanced data recognition software with accuracy rates approaching 100%, Scan Center's high-capacity databases and hardware systems have maximum throughput capabilities, allowing ClinPro to process thousands of forms and images easily.


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