Our medical imaging solutions improve the quality of data and reduce cycle time in imaging management
ICON uses leading edge technology combined with market leading expertise and best practice processes to streamline the management of images during clinical trials.
With over 20 years developing leading-edge core laboratory technologies, advising on FDA Guidance Document input and delivering over 25 FDA approvals our experts have the most experience in delivering medical imaging services. Our medical imaging experts will be able to advise you on the best technology according to your study protocol.
End-to-End Image Management
ICON imaging experts leverage Medidata's Rave Imaging unified, secure, cloud based medical imaging solution to manage end to end control of medical image data. This brings configurable and near real-time image access to sites globally; enhancing speed and facilitating analysis during clinical trials. It also means that you can gain visibility on all imaging activities to be able to spot trends and react faster.
Reducing Time and Increasing Quality
The Medidata solution enables smooth workflow management and flexibility by automating the distribution and review process after image upload. This automation reduces time by expediting the image assessment process, eliminating delays caused by physical imaging delivery and increases the data quality.
The solution is also a configurable platfrom which condenses typical go-live timelines and speeding up the time for set-up. Features include:
- Fully compliant system
- Robust APIs for integration with other imaging systems
- Real-time reporting
- Edit checks on all data prior to submission and distribution
Incoming image data is projected from the date of enrolment/baseline and ICON proactively tracks images received, outstanding, delayed, or non-compliant. Instream data is received by secure web-based image data transfer.
Compliant Proprietary Technology
MIRA is ICON's 5th generation, technology platform for collecting, managing and processing data to support all aspects of imaging. It enables management of clinical trial data in a proactive, well-controlled environment with complete audit trails.
MIRA is a comprehensive, permission based system that incorporates project teams, user roles, workflows, study timelines, and query/resolution.
Supportive Data Generation
MIRA allows users to import, associate, analyse, review, and database medical images and associated regions of interest for clinical trials. It also retains a centralised and secure repository of medical images associated with a particular clinical trial protocol.
Once images are received and databased, MIRA enables users to review, annotate images, and archive the assessments for the generation of supportive data describing clinical responses.
Inspection Ready Audit Trail
One of the major benefits of MIRA is the ability to store an audit trail including a history of events taken in the application by users as well as the status of data in defined task lists. To allow multi-user access, it has been developed with a client-server interface to a database repository linking it to a secure image storage repository.
- 24/7 real-time secure remote access
- Automated tools that allow readers to manipulate ROI
- 21 C.F.R. Part 11 compliant system
- Secure on-site and off-site data review systems
- Flexible and time-sensitive review processes
- Practical solutions for rapid data review
- Global accessibility
To learn more about our medical imaging technology and the benefits it brings to your trials please contact us to schedule a demonstration.