Clinical-Trials Solutions

Clinical Trials Solutions

AG Mednet provides the market-leading functionality, support and global footprint necessary to collect clinical trial image data globally, 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. The net result is faster, more efficient and higher-quality image-based clinical trials.

AG Mednet’s easy-to-use front-end, the Desktop Agent, was designed with investigators, trial coordinators and clinical-research associates (CRAs) in mind. The Desktop Agent requires minimal training, fits within existing site infrastructure and workflow without the need for IT intervention, and provides all the necessary modules to guide them through the submission process. Whether the images are on a CD/DVD, the file system or a PACS, the Desktop Agent enables sites to retrieve them with ease.

AG Mednet’s configurable Submission Quality and Compliance module checks that subjects were scanned using protocol-compliant image-acquisition parameters.

AG Mednet’s protocol-configurable De-Identification module ensures that data is properly anonymized prior to submission and that transmittal forms are error-free through sophisticated, protocol-based field-validation functionality. Additionally, investigators around the world are one call away from our support team which is available 24x7x365.

For core labs and sponsors, AG Mednet provides significant operating efficiencies. Gone are the days of courier or FTP-based systems when packages had to be opened and logged or computer file folders had to be checked for submissions, and where paper-based case report forms had to be scanned or entered into local systems.

Traditional investigator site workflow

AG Mednet integration with EDC and clinical trial management systems enable core labs and sponsors to eliminate numerous logistical steps in data submission processing: image-data is properly de-identified and flows directly into the trial’s image-management systems while the underlying electronic case report forms remain perfectly in sync with the image data and are automatically absorbed by the trial EDC environment. Because this data is able to leave the investigator site only after it has been checked for compliance by the AG Mednet system, data quality is significantly improved while data queries are dramatically reduced.

Investigator site automation

To complete the process, all participants in a submission, from the sender to the trial monitor to the sponsor, receive automated notifications when the data is successfully delivered to its destination. By using the AG Mednet Portal, all parties can review their transactions and download reports of activity by sender, core lab, sponsor and trial.

Through its patented technologies, AG Mednet operates across firewalls without the need to open any special ports either to send or receive trial data. In addition, AG Mednet’s Network Operations Center proactively monitors all of the traffic on its network, guaranteeing the successful receipt of every site submission for your trial. Finally, AG Mednet provides 24x7x365 support to insure that every site in a trial can successfully submit data at all times.

Workflow Advantages

The accelerating use of imaging in clinical trials adds yet another layer of complexity to the ever-increasing workload of investigator sites and core labs. Collecting images and underlying image data from hundreds of locations, applying quality-assurance processes to this data and completing the various analyses required are all demanding, time-sensitive activities that become significantly more difficult when simply accessing the data is a complex and unreliable undertaking. AG Mednet is the solution.

Collecting Image Data At Investigator Sites

Data collection begins at each investigator site, where most images are generated. The AG Mednet Desktop Agent provides numerous ways for an investigator site to collect image data: they can easily import exams from a CD/DVD, get them from the file system anywhere in the hospital, submit via the radiology department using standard DICOM protocol, or directly query the PACS and retrieve the required exam.

De-Identifying Image Data and Completing Transmittal Forms

Submitting image exams to a trial involves not only sending images, but also de-identifying them prior to sending, as well as accurately completing the detailed case report form required by the trial protocol. Ease of de-identification is an essential element of compliance, not just for the trial protocol, but also required by law (e.g. HIPAA in the U.S.) and local IRB requirements.

For this reason, the AG Mednet Desktop Agent 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), AG Mednet provides a pixel de-identification module that allows trial coordinators to automatically redact that information from every image in the exam.

Once all data has been properly de-identified, the AG Mednet Desktop Agent presents to investigators the required electronic case report form for the trial and ensures, through data and workflow validation, that all site submissions conform to the trial protocol.

Receiving Image Data

Processing large volumes of courier envelopes containing CDs and printed transmittal forms is unwieldy and expensive. AG Mednet provides the industry’s leading platform for flow-through processing of image data. Submissions by investigator sites arrive electronically to one or more trial repositories, where QA processes beyond those done automatically by our platform can be undertaken before commitment into the analytical process. With the Desktop Agent’s many validation tools, invalid submissions are significantly reduced while the overall QA process is enhanced. Additionally, transmittal-form data can be not only printed but submitted directly to one or more EDC and clinical trial systems while always maintaining its unique link to the underlying images with which it was delivered.

Regulatory Compliance and Extensibility

With AG Mednet, regulatory compliance is always in the forefront. Transfer and access security, record privacy, and the ability to capture data changes and transfer logs are all elements embedded in the AG Mednet platform. Additionally, AG Mednet’s plug-in architecture enables core labs and sponsors alike to easily integrate proprietary functionality.

Whether you are a core lab, sponsor or investigator site, AG Mednet can enhance data quality and reliability, increase efficiency and reduce data queries and cost while ensuring regulatory compliance in all your imaging trials.