ERICA - GCP-compliant image management in clinical trials

Diagnostic imaging serves as a powerful tool for the assessment of efficacy and safety in clinical trials. While the benefits of imaging in clinical trials are obvious, the associated operational challenges are frequently underestimated. The accepted (DICOM) standard of medical images does not support the organization of images in file systems, and the use of clinical image storage software (PACS systems) is not appropriate in the clinical trial context.

Based on more than 17 years' experience in imaging trials, pharmtrace developed the cloud-enabled GCP-compliant image management platform ("ERICA" - Electronic Read and Independent Case Assessment). This proprietary and highly scalable solution supports all imaging-related processes and workflows as required by current guidelines and good clinical practice, and provides a convenient and flexible interface for independent readers.

 

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Images can be securely uploaded into the ERICA warehouse by site personnel using an up-to-date internet browser. All images are anonymized during image upload. In the image warehouse, images are automatically checked for compliance with image acquisition and reconstruction parameters using information stored in defined "image header" data fields. ERICA allows customization of further workflows like image quality control by technicians and/or medical experts. All image quality control results are transparently stored. After image quality control and resolution of all queries, images are released for the independent read.

The immediate benefit of ERICA for sponsors is the transparency it brings to the imaging part of a clinical trial. ERICA not only provides sponsors with direct access to image data, it also possesses a comment function so that sponsors can flag selected images for later use (e.g., in study reports), and provides 24/7 access to relevant key performance metrics. Standard reporting includes an up-to-date inventory of all trial images that can be easily reconciled against visit dates in the clinical database.

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image management - traditional responsibility split (ERICA)

 

In its "traditional" configuration, pharmtrace administers the ERICA platform for all study-related image workflows. Sponsors may have access to the ERICA platform with access to images and trackers. In addition, pharmtrace offers ERICA in a "Software as a Service" bundle which allows sponsors to administer their own ERICA instance (more information is provided here).

 

 

ERICA key features

  • direct image upload
  • image anonymization
  • automatic DICOM header image QC
  • medical review module
  • e-mail notifications
  • device-independent image access and review
  • customizable user roles
  • comment function
  • structured image export
  • standard and non-standard image analyses with FDA-cleared image viewer
  • eCRF module
  • import of patient data for display during image reads
  • adjudication module
  • audit trails
  • comprehensive reporting
  • compliant with applicable regulations
    (GCP, 21 CFR 11, GAMP5, HIPAA)