“Image is everything,” as the saying goes, and that's no less true in the world of clinical trials. In light of that, management services organization RadMD and AG Mednet are teaming up to bring a new imaging option to the table for trial sponsors. In a recently signed partnership agreement, the companies will use Judi // Imaging to manage site reads and “Collect and Hold” image operations to support global clinical trials in any therapeutic area.
Judi // Imaging, part of AG Mednet's technology platform, offers trial conductors functionality, support and a global footprint for collecting clinical trial image data. This technology properly de-identifies participant data to comply with regulatory standards and applies automated quality-assurance processes to ensure data is protocol-compliant and usable before delivering it securely to one or more trial repositories.
“It’s time to standardize a Collect and Hold offering for the life-sciences industry. That’s exactly what we are doing by coupling the history and expertise of RadMD with AG Mednet’s Judi technology platform,” said Abraham Gutman, president and CEO of AG Mednet. “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. 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.”
Under this agreement, RadMD intends to launch a new service for clinical trial sponsors that don't necessarily need a blinded independent central review, but who do require high-quality site reads and access to trial images. RadMD will train site readers in the use of its BRITI (Blinded Reader and Investigator Training Institute) on study-specific read criteria, and will leverage Judi // Imaging for the collection, quality-control and storage of image time-points for real-time access. RadMD offers labs and trial sponsors medical experts when it comes to evaluating imaging timepoints to determine eligibility, disease progression, efficacy and safety in clinical trials that feature medical imaging endpoints.
“Collect and Hold imaging in trials provides a cost-effective alternative to sponsors who are not prospectively planning BICR. 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,” Dr. Rick Patt, cofounder and principal of RadMD, commented in a press release. “This new process nets improved confidence in site read results while giving sponsors control of their imaging database. The combination of RadMD’s expertise together with AG Mednet’s automated Submission Quality and Compliance capabilities, advanced storage and remote viewing makes this partnership offering a new and unique targeted solution for sponsors.”
This new service, an “imaging insurance policy” according to an AG Mednet press release, will allow companies to improve the quality of their image interpretations while also providing them with a cloud database for easy access to their images. The system will include integrated FDA-compliant workflows, structured site reads, cloud storage and desktop image access.
In other recent partnering news for AG Mednet, the company announced a few months ago that it was providing Judi // Imaging services to Qynapse, a French medical technology company that offers a cloud-based solution for customers to support accurate diagnosis, prognosis and drug efficacy measurement for central nervous system diseases.
“AG Mednet helps us deliver valuable information on time for the delivery of targeted and successful clinical trials,” remarked Olivier Courrèges, CEO of Qynapse. “We receive imaging data from multiple sites in multiple countries, and it must be compliant, anonymized and secure. Judi Imaging checks all those needs and more.”