Professional skills are required for integrating modern imaging into clinical studies. The range of established imaging modalities is broad and the devices are manufactured by different companies. Each device again offers many setting opportunities. It is therefore critical to design a study protocol where evaluation of selected variables is relevant and possible for all devices. Data acquisition must be feasible for the study center setting and impose the least burden for each individual patient. We offer extensive expertise in imaging protocol design, definition of variables and image capturing optimization.
At the beginning of each study, we provide assisted certification services for each study site and operator to ensure the imaging equipment as well as its settings and the procedures are suitable for the investigation. Based on our client needs, we provide a training manual and guarantee to properly advise each operator before and during the trial.
Site Monitoring Support
Throughout the study, we monitor the quality and performance of images and processes tightly and work closely with sponsors and sites to improve the overall process. Our study operations management team is always approachable and solves upcoming issues in an efficient, process- and partner-oriented manner.
Patients and potential study participants need to be included in a clinical study according to strict and predefined in- and exclusion criteria. We offer the service to rate the relevant images and parameters in an unbiased way in order to guarantee a blinded judgement if study inclusion is justified and reasonable.
Imaging data sets are prepared and preprocessed for optimized image analyses. Images are analyzed either by conventional manual readings or by validated automated algorithms developed by the VRC and OPTIMA group in-house, depending on the protocol and study requirements. Analyses include conventional biomarker identification as well as qualitative and quantitative assessment of biomarkers.
Data Handling & Statistics
We provide high quality support for sponsors and investigator. Our online "drag and drop" formats for uploading images to the VRC is customer-friendly, fully automated and easy to use. Uploaded images are real-time tested against a predefined set of quality standards and checked manually for, for example, certification of sites or operators to guarantee best quality control. Once the data is stored in our systems, the sponsor and investigator are able to access a broad set of study-specific statistics.
We furthermore provide customized reports to simplify the interaction with our client database and support efficient data interpretation.