pharmtrace klinische Entwicklung GmbH

pharmtrace is an independent imaging CRO providing strategies and solutions for clinical trials.

pharmtrace provides flexible services and a global reach to meet your imaging endpoints. We provide expert support related to imaging methodology during protocol design, site qualification / training, collect and store images from trial sites in our proprietary total image management system (ERICA) during study including an independent image analysis by expert physicians with comprehensive evaluation and reporting.

Our experienced team and international medical specialists network ensure that your investment in medical imaging delivers meaningful data.

With our GCP compliant image management platform (ERICA) we support you in the generation of robust data to convince authorities and decision makers by reducing "data noise". We deliver imaging data that comply with protocol stipulations and GCP and meet the FDA Guidelines (2011 & 2015) on imaging end-points in clinical trials.

pharmtrace’s ERICA is a tried and tested platform that facilitates the collection / centralization and storage of clinical trial images in a GCP-compliant manner.

ERICA allows participating clinical sites to upload acquired image data to a centalized study specific image warehouse. All images are organized in a file structure by study – patient number – visit – image series.

Additional features include

• real-time overview of study progress including access to KPIs
• automatic anonymization during image upload
• automatic technical Quality Control including check for compliance with Imaging Charter
• generation of automatic queries by e-mail for protocol deviations
• facility to selectively download and distribute QCed images to specific Readers

ERICA supports all imaging related processes and work flows as required by current guidelines and good clinical practice, and provides a convenient and flexible interface for independent readers.

In 2017 pharmtrace launched its tried and tested GCP-compliant image management system (ERICA) as a “cloud enabled” SaaS ("Software as a Service") platform.

ERICA-SaaS empowers customers to directly manage their clinical trial images and to take full control of all imaging-related workflows. pharmtrace provides the GCP-compliant image management platform with ongoing technical support while you take control. You directly manage your image data, selectively authorize user(s) access within defined (customizable) roles, and check process quality and study progress using the built-in reporting module.

This proprietary and highly scalable management solution (www.pharmtrace.com/en/image-management/erica-saas/ ) supports all imaging related processes and work flows as required by current guidelines and good clinical practice, and provides a convenient and flexible interface for independent readers.