AG Mednet provides client services to investigator sites, the core lab and sponsor throughout the life of a clinical trial, from trial set-up to deployment and extends to investigator sites until trial completion. Each aspect of the trial is managed by a dedicated AG Mednet resource.

Custom Trial Set-up Process

Every clinical trial using electronic image submission is uniquely configured in our network. This includes telecommunications infrastructure configuration, protocol dependent de-identification and eCRF, a standard Part-11 transaction log, and set-up of sites and users with unique credentials. AG Mednet follows a strict set of Standard Operating Procedures. Every set up goes through a stringent validation and user acceptance process applied to the clinical trial workflow. All of these must pass before trials are released for customer use.

Image Network Infrastructure Configuration
Basic trial set-up includes network configuration, testing and validation of the image network infrastructure required to securely gather, route, and deliver any DICOM or non-DICOM image set from investigator sites globally to the designated trial repository. Network configuration can include the set-up of web-service messages with the image and form data for integration to adjacent clinical trials systems. Every trial workflow configured in the AG Mednet network is a unique workflow, complete with independent audit logs and security keys to ensure Part-11 Compliance.

Standard Part-11 Transaction Data Set
Each trial is configured to capture a complete log of all transactions, image data transfers, and form data. These extensive and detailed records can be provided to imaging core labs and sponsors at the completion of the trial.

Site Set-up
AG Mednet provides easy setup of investigator sites and management tools to enhance image-based data collection. Each individual, whether it be the research associate at a site, country monitor, or sponsor project manger, is provided a unique username and password by AG Mednet to access the Desktop Agent, the AG Mednet portal, and all training materials.

Advanced Trial Features

Clinical trial set up features typically include custom configuration of protocol-specific de-identification for submitted images, fully-validated custom data transmittal forms, and other advanced features such as the DICOM clinical trials module

Trial-Specific De-Identification Of DICOM Study Metadata
AG Mednet provides the most advanced, integrated de-identification functionality in the industry. With flexible configuration capabilities, de-identification templates can be created for each trial enabling sites to achieve full annonymization. Each trial that employs AG Mednet’s de-identification tool is configured with automated validation to ensure compliance for a given trial protocol. In trials using de-identification, this capability ensures that images are properly annonymized prior to leaving the sender’s computer.

Custom Transmittal Forms
AG Mednet provides a fully-validated transmittal form management tool configured according to each protocol’s requirement. Transmittal forms include configurable validation parameters for each data entry thus eliminating the great majority of user generated errors when completing this requirement.

Clinical Trials Module
AG Mednet has implemented the DICOM Clinical Trials Standard, which can be configured per trial to provide additional, protocol-dependent values to be stored with the image exams. This capability integrated with an EDC system provides for full connectivity and data exchange between both systems. Trials using this level of integration can expect to reduce significantly the reconciliation tasks required when locking the trial database.

Ongoing Trial Support

AG Mednet provides full support throughout the life of the trial. All transactions are proactively monitored and we provide a Global Help Desk to answer any customer needs. Please read more about AG Mednet’s 24x7x365 Support.