pharmtrace is an independent CRO providing strategies and solutions for clinical trials. pharmtrace offers flexible services and a global reach for studies with imaging endpoints, radiopharmaceuticals, and radiological interventional procedures. pharmtrace’s experienced team and international medical specialists network ensure that your investment in medical imaging, radiopharmaceuticals and radiological interventions delivers meaningful data. With our GCP compliant image management platform (ERICA) we support you to generate robust data to convince authorities and decision makers by reducing “data noise". pharmtrace’s customers include biotech and academia, as well as internationally engaged pharmaceutical companies and device manufacturers.
ERICA provides a total image management solution that fulfils the rigorous GCP standards set by the EMEA and FDA for clinical trial data. Validated in numerous clinical trials, ERICA is a powerful project management tool that gives direct oversight and control to ensure compliance of image acquisition with study protocol and to create a centralised inventory / database of “clean” QCed images ready for read and evaluation.
Wolframstrasse 93-94, 12105 Berlin, Germany
phone: +49 30 63 222 700
pharmtrace provides highly specialized services related to all aspects of imaging in clinical trials:
pharmtrace's proprietary "ERICA" image database and reading system ensures efficient processes and full transparency for sponsors. All services are provided in accordance with the FDA’s draft guidance (August 2011 and March 2015) for Medical Imaging in Clinical Trials.
Learn more about ERICA - our GCP-compliant image management solution.
pharmtrace provides and organizes all aspects of clinical trials including
All clinical services are provided in accordance with the current ICH-GCP guidelines, the respective study protocol, any applicable local law, and applicable SOPs.
pharmtrace experts have extensive experience in the use of imaging and biomarkers in planning and executing clinical strategies including the strategic management and direction of major clinical development programs.
Consulting services include support in regulatory meetings, due diligence and medical need assessment as well as the creation and optimization of clinical development plans that incorporate medical imaging. pharmtrace is closely linked to the "Competence Network Life Sciences“ (CONELIS). This network provides comprehensive support to select, implement, manage and report solutions for all developmental phases from a regulatory, market and operational perspective.