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Phase IV Drug Trial


Visbion’s Unique Technology Employed in Clinical Studies

As a leading information technology solutions provider, Visbion brings together a unique combination of specialist expertise with innovative, robust technologies which provide solutions to complex connectivity and image management challenges within the Healthcare, Veterinary and Life Sciences Markets.

Visbion’s solutions are deployed to meet the very real and difficult challenge of information connectivity and have been developed to meet the wide range of challenges of combining both data and image in multiple geographically distributed centres; either locally, regionally or indeed globally.

Clinical trails today rely more and more on advanced imaging technologies to ensure they demonstrate their effectiveness. In therapeutic areas such as Oncology, medical imaging is now a key element of the trails process. With trials taking place on a global or continental basis, further challenges are placed upon technology to support the trial process.

On this basis, Visbion’s Image World solution was selected to provide customised technology for a 4 year, Pan-European image-based clinical trial. Spanning 6 countries and multiple co-ordinating centres, the study requires both images and data to be stored together, with the ability to upload, view and report on the findings at any location around Europe.

Overview

  • The study is centred at 6 locations across Europe, supported by satellite locations in each country
  • Scans are performed at all satellite locations and the resulting images are sent on CD to the study co-ordinating centre in that country
  • Using Visbion Software, the CD’s are checked and the images are encrypted, compressed and uploaded to Visbion’s Image World
  • The system pseudo-anonymises the images; giving each patient a unique identifier that can only be tracked back to an individual by the overall project co-ordinator
  • Each image is reviewed by a panel of clinicians who provide a report on the scan via Visbion’s web portal
  • The report and the image are stored together in the Image World archive and will form part of the trial

The Solution

  • Image World provides a single secure archive for both images and study data with the ability to view these records through one intuitive, web-based interface
  • Image World utilises DICOM and HL7 integration standards and is fully 21CFR Part 11 Compliant
  • The system has full data encryption in place and uses lossless compression for improved upload speed and data transfer
  • Full audit trail capability is built-in, down to individual user and individual scan level


Stefan Claesen, Visbion’s CEO said
"Visbion recognises that each Clinical Trial or Study is unique and to meet this challenge, Image World can be fully customised to create a trial-specific workflow. We also have an exceptional combination of individuals to advise our customers on the potentially complex problems they face and the alternative solutions that can be made available. Our aim is to enable our clients to identify optimal solutions to their specific business needs."

With imaging playing an ever increasing part in Clinical Studies, Visbion is dedicated to the continued development of leading-edge solutions to meet the demanding needs of the Life Sciences sector.