Judi // Imaging

Judi // Imaging provides the market-leading 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.

Image Management

Imaging Workflow enables sponsors, core laboratories and CROs to guide the process from collection to interpretation and reporting. Judi // Imaging’s advanced workflow platform is configured to ensure every step is followed by every participant, from investigator site to image QC and interpretation, ensuring that image data is properly de-identified, received, interpreted and stored.

Workflow Management

Judi // Imaging’s Workflow platform allows sponsors, core laboratories and CROs to follow their image data seamlessly starting at individual investigator sites all the way through interpretation, storage and archival. The platform enables true automation of the entire medical image lifecycle for any trial. The system can be configured to mirror the preferred process workflow chosen by the sponsor, core lab or CRO, enabling de-identification and QC automation, multiple reviews using the Judi // Imaging viewer, eCRFs at each step, audit trail, storage, reporting and archival.

Experience

AG Mednet has more than 10 years of experience assisting sponsors, core laboratories and CROs in the collection of both DICOM and non-DICOM medical images in support of their clinical trials. We have been awarded more than 1,100 clinical trials across all therapeutic areas. With more than 58,000 registered users across thousands of investigator sites in 80 countries, AG Mednet manages hundreds of millions of images each year.

Contact us to learn more about how AG Mednet and Judi // Imaging can help automate, expedite and improve outcomes in your clinical trial.

Explore Features
Workflow Management

It’s more than image transfer – it’s complete image management. For clinical trials collecting medical images, transferring them from investigator sites to a trial repository is not enough. Image data sets must be collected, properly de-identified and go through a rigorous multi-step quality control process. Then they must be analyzed by one or more radiologists before analyses are filed with the rest of the trial data. Judi // Imaging workflow management allows sponsors, core labs and CROs to define what these processes are, and automates the steps to ensure that all data is properly acquired and analyzed. With Judi // Imaging’s Workflow Imaging platform, sponsors, core labs and CROs never need to worry about developing and maintaining their own internal systems, but can focus on their core competencies in trial management and data analysis.

De-Identification

Respecting and abiding by patient privacy rules is paramount. AG Mednet is serious about all privacy requirements including GDPR, HIPAA and other national laws and regulations. Not only is the Judi // Imaging platform compliant, but AG Mednet also implemented the new Privacy Shield policies as agreed by the EU, US and Swiss authorities.

Submitting image exams to a trial involves not only sending images, but also de-identifying them prior to sending. Ease of de-identification is an essential element of compliance, not just to satisfy international laws, but also to ensure proper conformance with trial protocols, and local IRB requirements.

For this reason, Judi // Imaging provides a powerful, protocol-configurable de-identification function which guides the sender, validating entries and preventing exams from being submitted until they comply with the protocol and regulatory requirements. For exams that have patient-identifying information viewable directly in the image (e.g., digital x-ray, ultrasound, DXA), Judi // Imaging provides an integrated image redaction/pixel de-identification tool that allows trial coordinators to redact PHI from the exam.

Automated QC Checks

According to industry research, more than half of all image-related clinical trial query stoppages result from preventable human errors, causing an average delay of up to seven weeks.

AG Mednet recognizes that the current system is imperfect, and in response created its Submission Quality & Compliance module (SQC) – an additional layer of automated quality assurance – to reduce submission error rates and bring preventable delays to zero. This module is the first quality-assurance software developed specifically to detect errors at the investigator site prior to data submission to accelerate clinical trial decision-making.

Judi // Imaging’s SQC features include the ability and flexibility to:

  • Confirm that all parameters in a medical image set are compliant with predetermined protocol ranges at the exam, series and instance level
  • Identify and alert for missing information and instances
  • Assure that specified views (e.g., coronal, sagittal, axial) are present
  • Send specific image series so only the protocol-required data arrives at the trial repository
  • Verify that the required series were taken in the proper sequence
  • Remove unwanted structured reports that may contain personal health information
  • Perform longitudinal analysis of image parameters
  • Customize reporting to senders, core labs and sponsors including acknowledgements with electronic signatures
Cross-Study Reporting

Judi // Imaging provides advanced reporting capabilities including:

  • Advanced user-configurable dashboards
  • Standard reports
  • Ad-hoc reporting tools
  • Reporting across studies and across programs
  • Multi-format data exports
  • Data warehouse for user-defined queries
Storage Services

Judi // Imaging storage services provide a seamless mechanism to store clinical trial image data. Developed from the ground up to be a robust Part 11 compliant repository, our storage solutions are an ideal complement to Judi // Imaging’s quality enhancement capabilities.

Use Judi // Imaging with integrated storage to collect, QC and store image exams. Review your image data using any of our available options: the Judi viewer, your own WADO compliant viewer, or download your DICOM images directly into your local workstation.

If you have geographic constraints for your data, such as having to store it in the European Union because of data custody regulations, Judi // Imaging can provide you with regional storage in multiple locations in Asia, Australia, South America, Europe and the US. You can use Judi // Imaging to achieve your redundancy, availability and disaster recovery requirements, as well as to help manage remote access to images by outside readers. Since Judi // Imaging can simultaneously deliver image submissions to multiple locations, copies of every exam can flow directly to both your in-house repository and redundant storage or long-term archive. Judi // Imaging provides you with on-demand infrastructure expansion without increased capital or FTE investments.

EDC/CTMS Integration

Judi // Imaging provides two-way integration with the leading EDC platforms, as well as a variety of clinical trial management systems. By making extensive use of the DICOM standard’s clinical trial meta-data definitions, a site sender using Judi // Imaging is presented with real-time EDC/CTMS details such as site-enrolled patients and timepoints enabling them to pick the specific option for the data they are preparing to send. Once they complete their submission, all additional information they are sending, including their entries in case report forms, is automatically fed back into the EDC/CTMS without human intervention. This complete cycle reduces errors and the queries they usually generate.

DC/CTMS integration benefits include:

  • Elimination of many common opportunities for errors at the site
  • Reduction of data entry costs
  • Real time reconciliation of imaging submissions