ICON Announces ICONIK -- An Integrated Technology Solution Providing a Single View of Study Information
ICONIK 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 in new and unique ways. 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 singe view of study information. Both CRO and sponsor teams can easily access study information and trends anytime, anywhere from a secure, web-based interface. A 21CFR compliant solution, ICONIK enables sponsors to more easily meet regulatory requirements by providing an online, end-to-end audit trail of study data for FDA submissions and post-submission queries.
As part of the ICONIK solution, ICON is the first CRO to fully deploy 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.
“Clients are looking to make better informed and faster decisions and need real-time access to safety and performance data, rather than ad hoc programmed output, to make these decisions,” commented Mike McGrath, Senior Vice President, Information Technology at ICON. “ICONIK provides true 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. Using the information from ICONIK, we will help our clients in their drive to adopt more efficient and effective development programs. We are the first CRO to implement Oracle Life Sciences Data Hub to consolidate our clinical data and we are on track to roll out the next phase of ICONIK, which will include the integration of imaging and laboratory data.”
About ICON plc
ICON plc is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. The Company specialises in the strategic development, management and analysis of programs that support clinical development - from compound selection to Phase I-IV clinical studies. ICON currently has around 7,800 employees, operating from 77 locations in 39 countries.
Further information is available at www.iconplc.com
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Contacts
Susan Dempsey
ICON plc
+353 1 291 2088
Rosie Allan
Weber Shandwick
+44 (0)20 7067 0190