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AQUADIC

Motivation

In the field of clinical research diagnostic imaging becomes increasingly more important. Diagnostic imaging makes success of therapeutic measures visible and quantifiable (e. g. reduction of tumor volume in therapy, represented by means of computer tomography). For working with these image data there are high regulatory requirements which derive from the GCP regulations (GCP - Good Clinical Practice) and medicinal Product Act. As a result of existing conditions image data management is characterized by a high degree of documentation and quality assurance. Such tasks are very time- and stuff consuming. So far, IT-systems that assist or automate workflows and that are characteristic for research, are not commercially available.

Project objectives

Within the scope of AQUADIC image data from different study centers shall be collected. From these images, quality assurance as well as the storage and proper availability for a blinded evaluation in compliance with GCP shall be conducted in an improved manner. Quantitative results of image review are to be kept immediately in a validated study database. All processes of image storage, image review and image evaluation are accurately recorded and are stored in an 'audit trail' which fulfills the high regulatory requirements in the field of international clinically oriented pharma research.

The use of a scalable IT-based solution permits reduce manual workload. This is an obvious competitive advantage for study centres as well as for the companies involved in this process. The combination of different fields of application such as study centres, IT provider and contract research organizations opens up new foreign markets for the affiliated companies of this project.

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AQUADIC

BMBF