Iconik from Icon is an integrated technology solution that provides a single view of study information to both sponsor and contract research organisation (CRO) teams.
The 21CFR-compliant technology provides immediate knowledge to study teams by allowing near-real-time access to study performance metrics, critical safety and efficacy data, and analysis of this data.
Iconik consolidates and standardises data from multiple sources, including CTMS, EDC, IVR and Epro, and combines the data with analytical, reporting and visualisation tools to provide a single view of study information.
Both CRO and sponsor teams can access study information and trends at any time, from anywhere, using a secure, web-based interface.
Iconik enables sponsors to more easily meet regulatory requirements by providing an online, end-to-end audit trail of study data for Food and Drug Administration (FDA) submissions and post-submission queries.
As part of the Iconik solution, Icon has fully deployed the Oracle Life Sciences Data Hub, which will form the backbone of the Iconik Clinical Data Repository.
Oracle Life Sciences Data Hub is a validated and secure repository that pools clinical and non-clinical data from multiple sources into a single environment where it can be analysed and reported to support better decision making.
Mike McGrath, senior vice-president - information technology at Icon, said Iconik provides data transparency and visualisation of all study data, from site selection through to database lock and enables clients to view critical safety and efficacy trends as they emerge.
