by John R. Fischer
, Senior Reporter | January 18, 2019
Management services organization RadMD has selected AG Mednet’s Judi // Imaging to manage site reads and “Collect and Hold” image operations for global clinical trials across all therapeutic areas.
The partnership forms the basis of a new service offered by RadMD for sponsors that do not plan blinded independent central reviews but require high-quality site reads and use of trial images in their work.
“Collect and Hold imaging in trials provides a cost-effective alternative to sponsors who are not prospectively planning BICR,” Dr. Rick Patt, co-founder and principal of RadMD, said in a statement. “With this process, site read quality and reliability is improved and a fully reconciled imaging database with remote viewing capabilities is provided to the sponsor throughout the trial.”
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Providing functionality, support and the global footprint needed to collect clinical trial image data, Judi // Imaging ensures regulatory compliance by de-identifying data, and applies advanced automated quality-assurance processes to verify that the information abides by protocols and is readily usable. Data is reliably and securely delivered to one or more trial repositories through the system.
Using its Blinded Reader and Investigator Training Institute platform, RadMD will train users on study-specific read criteria, deploying Judi // Imaging to collect, perform automated quality control, and store image time points to allow trial sponsors to access them in real time.
Further support can be found in the form of RadMD’s core labs and sponsors, which offer medical experts who can assess imaging time points to decipher eligibility, disease progression, efficacy and safety of trials that involve medical imaging endpoints.
Also included in the single package system are integrated FDA-compliant workflows, structured site reads, cloud storage and desktop image access.
The presence of these resources are expected to improve the quality of site interpretations for those in the pharmaceutical, biotech and medical device industries, while creating an accessible cloud database of their images and providing sponsors with a cost-efficient way of ensuring images are available for sponsor review.
“Collect and Hold imaging trials fall within an interesting space where, while the data may not be immediately necessary, when it’s required, it becomes indispensable and critical to determine therapeutic efficacy. At that point one must be sure that images were collected according to prospectively determined standards,” said Abraham Gutman, president and CEO of AG Mednet. "This can only be determined as soon as an image is uploaded by investigator sites and has gone through proper quality control procedures. Additionally, it is important that this imaging data be available for viewing remotely at any time by sponsors.”Back to HCB News