The use of imaging in clinical trials is gaining significant momentum, while the workload at investigator sites and core labs continues to increase.  Collecting images and image data from hundreds of locations, applying quality assurance processes to this data, and completing the required analysis, are all demanding activities that become significantly more difficult when getting the data is a complex and unreliable undertaking.  AG Mednet has the solution.

Collecting Image Data At Investigator Sites

Data collection begins at each investigator site where, in general, images are generated in an area other than where the principal investigator is located.  This may be a remote imaging site or the local radiology department at the hospital. The AG Mednet Desktop Agent provides numerous ways for an investigator site to collect image data.  They can just as easily import exams from CD/DVD, get them from the file system anywhere in the hospital, have them submitted by the radiology department using the standard DICOM protocol, or directly querying the PACS and retrieving the needed exam. 

De-Identifying Image Data and Completing Transmittal Forms

Submitting image studies to a trial involves not only sending images, but also de-identifying them prior to sending, as well as filling the proper submittal form required by the trial protocol.  Ease of de-identification is an essential element of compliance, not just for the trial protocol, but also for national confidentiality regulations (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 sending site, validating entries and preventing studies from being submitted before they comply with the protocol requirements.  In the same way, the Agent presents the required Transmittal Form for the trial and ensures, through data and workflow validation, that submissions conform to the trial protocol requirements.  Additionally, if the protocol calls for the use of the Clinical Trials Module for DICOM, the Desktop Agent provides the mechanism to ensure that it is properly utilized.

Receiving Image Data

Processing hundreds of courier envelopes containing CDs and printed transmittal forms is unwieldy and expensive.  AG Mednet provides the best platform in the industry for flow-through processing of image data.  Submissions by investigator sites arrive electronically to one or more trial repositories, where they can go through proper quality assurance before commitment into the analytical process. With the Desktop Agent’s many validation tools, invalid submissions are significantly diminished while the overall QA process is enhanced.  Additionally, submittal form data can be not only printed, but submitted directly to one or more trial databases, always maintaining its unique link to the images with which it was delivered.

Regulatory Compliance and Extensibility

AG Mednet has built a robust network with the need for regulatory compliance always in mind.  Transfer and access security, record privacy and capturing data changes and transfer logs, are all elements embedded throughout our platform.  Additionally, AG Mednet provides a plug-in architecture that enables core labs and sponsors alike to extend the existing robust capabilities with unique know-how developed internally.

Whether you are a core lab, a sponsor, or an investigator site, AG Mednet can enhance the efficiency and quality of your operations, reduce cost and increase reliability in all your imaging trials.