Imaging CRO WorldCare Clinical has launched a service that allows imaging data to be collected, standardized according to the imaging protocol, and held in a database until a central review is requested. The service--called Collect, Ready, Hold--uses the Boston-based company's WorldPro image management tech to acquire and prepare imaging data.
In 2004 the FDA put forth an initiative in which the agency began using imaging data to understand efficacy data, explains WorldCare Chief Medical Officer Dr. Richard Walovitch. Since then there has been an explosion of imaging technology used to analyze trials for oncology, Alzheimers and many other therapeutics areas. The problem, he explains, is that sponsors are collecting images but don't know how to store, retrieve or analyze them when the FDA asks for this data.
Collect, Ready, Hold is designed to help companies respond to regulatory agencies requests and streamline the review process. "This technology evolved through ongoing discussions with study sponsors," WorldCare Clinical President Rick Taranto tells FierceBiotech. "If the FDA asks for a central review of imaging data, the time and costs to sponsors can be significant. The service standardizes how the images are acquired and submitted from clinical study sites. WorldCare team members QC the images when they are received, and can catch any issues with the images that may need to be resolved. Then the data is stored and to be viewed at a later time."
WorldCare claims the service will cut time and site management costs by preventing sponsors from having to go back and collect images if a central review is requested. The technology is manufacturer-agnostic, so the DICOM images can be pushed to any CRO a sponsor chooses.
- here's WorldCare's release