Acquisition design

IXICO has expert knowledge in the most widely used modalities for clinical trials. We will help you define precisely what meaningful data can be extracted from images in your study, how to collect optimized images for that purpose and how best to obtain high quality and accurate results from analysis.

Site management & Logistics

Each time IXICO engages into a new project a new delivery team is formed including Project Manager, Image Analyst, Software Developer and Computer Administrator. This group will engage in the project to ensure that all images are acquired, transferred and processed. This service will include, among other tasks

• Qualify sites
• Train sites
• Prepare the appropriate documentation
  • Site operation guide
  • Site procedures and forms
• Liaise with the sponsor and sites
• Troubleshooting
• Screening and logging of the received data
• Perform initial quality control.
• Storing data

The key characteristics of this service are

• Streamlined solution to speed up the process
• Live progress updates to sponsor through a web browser
• Regulatory compliant procedures with full audit trail

Image Analysis

IXICO has world-leading image analysis technology developed by its founders in their academic research groups and integrated it into a workflow system for rapid configuration to customer requirements. This technology platform, combined quality management system can enable our customers in the pharmaceutical industry to obtain maximum value from imaging in their trials.

Key Characteristics

Flexible: The workflow has a full range of generic components that can be easily combined to a specified study. Examples of this are: Erosion Analysis from MRI, Atrophy quantification, DCE-MRI analysis, construction from volume CT.

Automated System with Quality Assurance: The core image analysis tasks are automatic, and semi-automatic stages. Our Quality Assurance Wizard, built in to the workflow enforces quality checking throughout the analysis pipeline with every image being checked and approved.

Interactive steps:The system incorporates in-house interactive tools so that steps such as ROI can be included if necessary. All actions implemented in this way are fully recorded, signed and incorporated to the audit trail.

Scalable: The systems runs on IXICO's in-house distributed computer cluster, a multiprocessor stable platform. This platform will be scaled on demand.

Compatible: The most common formats and protocols are used for Input and Output of this system (DICOM, Analyze, etc.)

Quality Management System (ISO 9001:2008 certified): The company as well as the workflow tools are under a strict quality system, almost paperless.

Audit trail (FDA 21 Part 11 in progress): All procedures, transformations and results from the workflow are stored in signed XML files that constitute a detailed electronic paper trail, enabling every processed image to be tracked back to its source.

Web Access: The system gives fully customizable access to each original and processed image which can then be analyzed through a secure web portal.