Imagys Solutions for an International Clinical Trial in Rheumatology

Imagys has been selected by the Therapeutic Research and Clinical Trial Division of one of the most prestigious pharmaceutical laboratories in the world.

Details of the clinical trial:

• Treatment trial for Rheumatology
• Length of trial: 18 months
• 30 international investigation sites located in Brazil, Czech Republic, France, Germany, Hungary, Italy and the United Kingdom
• 2 independent read experts in France
• Analysis of imaging data is critical for study endpoint decision
• 300 patients recruited; 200 retained for the trial
• 2300 x-ray exams uploaded, quality-controlled and analysed during the trial.

Imagys solutions are fundamental to the trial outcome. So how is Imagys involved in the trial?

Imagys partners with the laboratory to provide the following services for this clinical trial:

• Project management
• Design, development and validation of trial specific protocols based on generic Imagys modules
• Support and training for investigators, site teams and independent read experts
• Validation testing
• Creation and supply of administrative and technical files conforming to regulations
• Imaging data management system and infrastructure available 24/7

Imagys modules selected for this trial are:

• Clustered and redundant data infrastructure at the Imagys Data Centre
• Secure white rooms
• Secure international upload
• Centralised quality control
• Secure multicentre web-access (HTTPS) from PC and Mac
• Storage of DICOM image and results database
• Audit trail and tracking
• Centralised diagnositc viewer via remote access – no software installation required
• Certified “Medical Device” 15 year storage plan

EORTC selects Imagys

The European Organization for Research and Treatment of Cancer (EORTC) has selected Imagys solutions for installation at their European data centre in Brussels.

Imagys solutions will be used by medical imaging teams (radiologists and doctors of nuclear medicine) responsible for the multicentre independent read of files uploaded in trials run by the EORTC.

The Imagys solutions are crucial to the analysis of medical imaging files in oncology.

Imagys experts work with the EORTC to provide the following services:

• Project management
• Adaptation of generic Imagys modules for the EORTC
• Design, development and validation of additional modules specific to the requirements of the EORTC e.g. quality assurance and quality control
• Support and training for investigators, site teams and independent read experts
• Validation testing
• Installation and configuration of Imagys software modules on EORTC hardware
• Maintenance and technical assistance

Imagys modules selected for this trial are:

• Clustered and redundant data infrastructure at the EORTC Data Centre in Brussels
• Imagys API with EORTC upload interface
• Centralised quality control
• Secure multicentre web-access (HTTPS) from PC and Mac
• DICOM image database (PACS)
• Audit trail and tracking
• Centralised diagnositc viewer via remote access – no software installation required
• Software certified ISO 13485 and FDA

For more information about how Imagys solutions can be designed and adapted for your trial protocols call 00 33 2 40 92 26 13 or send us an email Cette adresse email est protégée contre les robots des spammeurs, vous devez activer Javascript pour la voir.