Following the concept of "total image management", pharmtrace core lab services start with preparing detailed image acquisition and handling instructions for trial sites, and the preparation of a site training program. From the first patient visit, sites are continuously supported in all imaging-related aspects, from patient preparation to support regarding imaging equipment settings and image post-processing. All pharmtrace activitities are geared to optimize imaging to reach study-specific objectives with minimum data noise and a minimum number of imaging-related protocol violations. Close contact with CRAs ensures that issues can be efficiently solved and sites supported in a timely manner. All image handling follows FDA guidance on imaging in clinical trials from 2018.
At pharmtrace, all image-related workflows are supported by the proprietary "ERICA" system - a dedicated, cloud-enabled GCP-compliant image warehouse and read platform. ERICA is built on more than 17 years experience in imaging trials. ERICA provides a robust platform for all image-related trial processes from image upload by trial sites to independent image reads with standard and non-standard criteria. ERICA is compliant with all applicable regulations (e.g., GCP, 21 CFR 11, GAMP 5, HIPAA).
After upload into the ERICA warehouse, all images are subjected to a rigorous quality control (QC). Typically, pharmtrace performs a 2-step QC: an automatic QC from the DICOM image header, and a QC by an experienced technician. In selected cases, a third QC step by a medical expert is added. All QC procedures are transparently documented in the ERICA system. If images do not fully comply with the defined study standards, queries are issued. Following sponsor requirements, queries are sent directly to the sites by pharmtrace, or provided to CRAs (or sponsor personnel) for resolution. pharmtrace routinely reconciles available images in ERICA against the list of imaging visits from the clinical database in order to identify missing images. Images are released to the independent image read only when all respective queries are closed and all required images are available to follow the correct sequence for the read. At any time, pharmtrace provides comprehensive reports according to sponsor requirements.
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Independent image reads at pharmtrace can be flexibly configured to allow standard and non-standard analyses in a GCP-compliant manner. pharmtrace has conducted image analyses with various modalities (CT, MRI, angiography, scintigraphy, SPECT, PET, PET-CT, PET-MRI, functional MRI, dynamic contrast-enhanced imaging, ...) using a broad range of assessment methods (RECIST 1.0/1.1, CHOI, quantitative imaging, SUV values, volumetry, ...). Please contact us for a detailed discussion of your requirements.