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Clinical Trials

Since 2004, we have been sustainably supporting our partners in our role as specialists in planning, conducting and evaluating image-based clinical trials. In this context, the interaction of partners from different fields leads to a high level of complexity. With our competent services we are glad to assist you in the field of imaging within your clinical study.

Project Management

Our experienced project managers coordinate the process of imaging within your clinical study. They are supported by a skilled team of medical imaging experts, comprising physicists, physicians and computer scientists. Furthermore, we have an excellent network of radiological institutes and practices available, which makes us an adequate interface between the sponsor, the radiological sites and additional partners.

Teams of experienced project managers, imaging experts and software developers
Interface between radiological sites, sponsor and additional partners
Coordination and monitoring of imaging activities within a study

Study Design

We are more than happy to advise you during the planning phase of your clinical study. Our experts assist you in choosing imaging techniques, protocols, optimized analysis methods and image based parameters.

Consulting on medical imaging and evaluation techniques
Definition of biomarkers und optimized analysis routines
Development of standardized study protocols

Site Management

A team of qualified site managers is in close contact with the radiological study sites. By competent technical support, also directly at the site, we guarantee smooth processes within your study, from the initiation of a site to the examination of the last patient.

Recruiting of radiological sites
Qualification of sites and evaluation of technical equipment at the site
Generation of training tools und documentation
Training of radiological staff at the site
Quality assessment of the sites
Direct contact for the radiological site

Image Quality Assessment

At mediri, the revision and quality assessment of all incoming image data is performed exclusively by qualified staff with years of experience in the field of medical imaging. The quality checks are supported by our software product AQUA (Automated Quality Assessment), which provides automated quality analysis of medical data.

At the stage of reviewing the incoming data a plentitude of information about the data is already available, such as deviations from the given image protocol and conspicuities regarding the image quality. Thus, particularly in multi-center trials, we can guarantee constant data quality and an efficient generation of quality reviews.

Quality assessment of all incoming data by imaging experts
Quality analysis of all relevant data
Completely automated analysis modules for the evaluation of image quality
Quality-metrics of the image data, e.g. signal-noise-ratio
Check of patient identities for follow-up visits

Quantitative Image Evaluation

Image-based biomarkers provide quantitative answers to the questions of your clinical study. Often, image post-processing is required to obtain these biomarkers.

Our workflow-management-system offers the possibility to embed either automatic, computer-aided or manual analysis procedures. These are for example applications such as segmentation of tissue structures, volume determination, or the evaluation of time series, which is required in perfusion or functional imaging.

Quantitative data evaluation using modern techniques, e.g. ASL-perfusion analysis
Modular image processing workflows
Extensive selection of evaluation modules, e.g. registration
Specialized evaluation modules for individual requirements

Central Read

The central reads are performed by radiological specialists. Our workflow-based data management tool allows for short processing times. Due to our web-based approach we can integrate a network of external experts. A flexible configuration of the system enables the execution of various read processes, such as „second read“, „double read“ oder „paired read with adjudication“.

Design and implementation of custom reading processes
Recruiting of qualified readers
Central workflow-management-system
Organization of reader trainings and support
Online-monitoring of the reader performance

Database Services

All processes are embedded in our central IT-platform mTRIAL. It combines the functionality of an image database with that of a process management system. All steps of the management, the quality assessment, the image processing and the image read are mapped in mTRIAL. By linking the database to these processes, all partners can efficiently and promptly access data of relevance to them.

Web-based IT-system as central platform for all partners of the clinical study
Database containing all study sites
Image database for storage of all image data

Partner

Company profile

For more than 10 years mediri represents expertise in medical imaging. An experienced team offers one-stop services to partners from the pharmaceutical and medical sector. Services range from designing the imaging protocols over data management and analysis to mediri’s support of processes like secure electronic transfer of image data, computer-based quality asses and a central image read by board certified radiologists.

Contact

mediri GmbH

Eppelheimer Straße 13
69115 Heidelberg

E-Mail: info@mediri.com

+49 6221 725 6970
Fax: +49 6221 725 6979