Thanks to our extensive experience in medical imaging, we provide state-of-the-art, fully integrated products and services for the management of medical images in clinical trials. Our dedicated operational teams are trained in GCP (Good Clinical Practice) on a regular basis, so that clients can confidently expect operational excellence for every project, no matter how complex. Our team provides:
Our team relies on advanced quality management systems to limit risk.
Keosys’ project managers are experienced medical imaging leaders with the relevant certification and therapeutic expertise to manage international trials. They provide members of the multidisciplinary project team with both internal and external leadership: Based on contractual and protocol requirements, Project Managers are charged with the oversight of all relevant functional areas involved in the project, and they serve as its main point-of-contact. In compliance with Good Clinical Practice (GCP), Keosys’ teams take a risk-based approach to project management, and measure efficiency and reliability with Key Performance Indicators (KPIs).
Our operational team qualifies each investigator site in the study to make sure that they are equipped with the appropriate hardware and processes to manage images as recommended in the Image Acquisition Guidelines (IAG). In order to guarantee high quality images in each trial, Keosys also tests image quality by using phantoms or test images. The members of each site are also trained in our technology and our in-house technical team is available to troubleshoot any issues that may come up along the way.
Our Imagys platform centralizes all imaging-related data and is accessible in real time by sponsors. The platform allows users to export data at anytime using their web browser. In addition, imaging data can be “pushed” to third-party EDC systems (Electronic Data Capture) to make sure all data is accessible in one centralized location, reducing the amount of reconciliation work needed. Our system are 21 CFR Part 11-compliant and include an audit trail feature that guarantees good data traceability.
Project Management and operational guidelines are outlined and explained in our Quality Management system, which is managed by our independent regulatory team. Our Quality Management System is certified ISO 13485, and we review it on a regular basis with our senior management team. We also participate in regular client and regulatory audits, and are committed to providing quality products and services to each and every one of our customers.