IT SOLUTION WITH A HEART HANNOVER MEDICAL SCHOOL TRUSTS TRIALCOMPLETE FOR ITS CLINICAL TRIALS

  • Structured, data protection-compliant uploading of (image) data to appointment schedules
  • Pseudonymization and traceability of data mapping
  • Consolidation of data from different sources (medical and imaging methods)
  • Solution: TrialComplete, developed by Telekom Healthcare Solutions
  • Single point of truth for data
  • Operation in a T-Systems data center
  • Needs-based use as a web application

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“We are very pleased that Telekom Healthcare Solutions developed a system that securely merges both MRT image data and trial data.”

Prof. Samir Sarikouch, Head of the clinical trial and senior physician at Hannover Medical School

THE CHALLENGE

The multiyear study generated many terabytes of data from the imaging processes. This data is supplied by many different PAC (Picture Archiving and Communication) systems from the connected hospitals in Moldavia, Italy, France, Belgium, the United Kingdom, and the Netherlands. But the images are only one part of the study. To enable valid claims, they have to be linked with the patients’ corresponding medical data, but such data is usually stored in separate systems. Another challenge was posed by the pseudonymization of the data, which was necessary for data protection reasons: experts for clinical trials assume that a significant portion of the collected data cannot be used, because the data mapping cannot be clearly reconstructed.
The process for the clinical trials required a solution that not only made it possible to reconstruct the mapped data over long trial periods, but also reliably protected the personal data of the participating children and gave targeted support to collaboration on the project.

THE SOLUTION

“These requirements are obvious – yet no suitable system was available on the market,” explained Prof. Samir Sarikouch, head of the clinical trial and senior physician at MHH. A large portion of the research work was still conducted manually. The Clinic found this method to be unacceptable – especially for a project with an international dimension like this one. TrialComplete, the trial management system developed at the time by Telekom Healthcare Solutions, enables pseudonymization and archiving of both the medical and imaging data in a standardized format (DICOM), supporting the trial process. The web application is accessed using browser software on hospital PCs, with the same procedure used by the participating hospitals throughout Europe. There is no need to install separate software or purchase licenses. The application itself runs in a T-Systems data center – ensuring that the infrastructure meets all demands for security and data protection. As such, TrialComplete was ideally suited to ESPOIR. “TrialComplete gives researching scientists a ‘single point of truth’ – the data is stored centrally, where we can sort and process it as needed. We can see the filtered data records completely and instantly, to get started with our work,” summarizes Prof. Sarikouch. Be-cause it runs in a private cloud, TrialComplete is scalable. If the number of participants in a trial increases significantly, the cloud can provide additional resources, ensuring user-friendly work can continue.

 

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