directly create & manage your own clinical trial image database

With ERICA SaaS ("Software as a Service"), pharmtrace enables sponsors take full control of all imaging-related workflows. pharmtrace provides the GCP-compliant image management platform, while you take control. You can directly manage your image data, provide user access within defined (customizable) roles, and check process quality using the built-in reporting module.

The cloud enabled ERICA image management platform also allows you to assign responsibility for distinct imaging-related processes across different parties in accordance with your organizational structure, and to document performance. ERICA provides the flexibility for implementation of different types of "distributed responsibility" (see one possible example, below).

ERICAImageMgt.jpg

example of distributed responsibilities with the ERICA SaaS offer - the sponsor administers the system, pharmtrace provides support as needed

 

The GCP-compliant platform will be hosted in a certified German data center with backup and symmetric connection to the high‐speed internet backbone allowing very fast data up‐ and downloads (hosting in professional datacenters in other geographical areas is possible).

pharmtrace experts are always available to ensure continuous technical, medical and regulatory support.

Further details on ERICA and its configuration options are provided here.

 

ERICA key benefits

  • participating sites upload acquired image data via a secure internet connection to the central image warehouse
  • all images are automatically anonymized during this upload
  • all images will be organized in a file structure by study – patient number – visit – image series
  • automatic quality control (QC) from the image DICOM header for adherence to required acquisition and reconstruction parameters
  • generation of automatic queries by e‐mail for deviations from the expected quality standards which will help the site(s) to correct issues
  • ability to download all or selected images in a structured format
  • ability to view the images on any computer, comment on individual patients, visits or images, and assess images based on predefined criteria in an uncontrolled read situation
  • tracking of all interactions with the ERICA system in an audit trail (compliant with all applicable regulations like GAMP 5, GCP, 21 CFR 11)