BOSTON, Jan. 15, 2019 /PRNewswire/ -- RadMD, an expert-based Management Services Organization focused on imaging in clinical trials, has signed a partnership agreement with AG Mednet to use Judi // Imaging to manage site reads and "Collect and Hold" image operations in support of global clinical trials across all therapeutic areas.
Through this partnership, RadMD will launch a new service to support sponsors that are not planning a blinded independent central review (BICR) but do value high-quality site reads and access to their trial images. RadMD will train site readers using their BRITI (Blinded Reader and Investigator Training Institute) on the study-specific read criteria, and utilize Judi // Imaging to collect, perform automated quality control and store image timepoints for real-time access by the trial sponsor.
The service acts as an imaging insurance policy, enabling pharmaceutical, biotech and device companies to improve the quality of site image interpretations while creating an accessible cloud database of their images. With RadMD's solution, sponsors have an economical way to ensure that images will be available for sponsor review. This single package system includes integrated FDA-compliant workflows, structured site reads, cloud storage and desktop image access.
"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," said Dr. Rick Patt, cofounder and principal of RadMD. "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."
Judi // Imaging by AG Mednet provides the functionality, support and global footprint necessary to collect clinical trial image data, properly de-identify it to ensure regulatory compliance, apply advanced, automated quality-assurance processes to insure the data is protocol-compliant and readily usable, and deliver it reliably and securely to one or more trial repositories. RadMD provides core labs and sponsors with medical experts evaluating imaging timepoints to evaluate eligibility, disease progression, efficacy and safety in clinical trials involving medical imaging endpoints.
"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."
RadMD was founded in 2006 as an imaging management services organization, focusing on managing site reads, performing independent image reviews, and training of site personnel on trial imaging issues. RadMD is the acknowledged leader in providing highly trained and experience independent image reviewers from its global group of nearly 600 physicians. Their reviewers have performed independent reviews of images from more than 450 oncology trials that have led to numerous drug approvals. They have trained more than 10,000 site readers and personnel on imaging criteria, techniques, and image transfer.
About AG Mednet
AG Mednet is the leading quality compliance partner for image data submission and collection, as well as endpoint adjudication and adverse event adjudication workflows. The company is a leading proponent of zero-delay clinical trials and has supported more than 1,100 global trials. Dozens of adjudication protocols are managed by sponsors and CROs using Judi. More than 58,000 registered users across thousands of investigator sites in more than 80 countries use AG Mednet to adjudicate myriad events in projects sponsored by each of the world's top pharmaceutical, biotech and medical device companies.
SOURCE AG Mednet