Appropriate information at the right time leads to better decision making. According to Mike McGrath, senior VP, Information Technology at ICON plc, the company’s clients require real-time access to safety and performance data, rather than ad hoc programmed output, to make better informed and faster decisions.
In an effort to provide clients with an integrated technology solution offering a single view of study information, ICON – a provider of outsourced development services – has launched ICONIK, an integrated technology solution delivering a single view of study information to both sponsor and clinical research organization (CRO) teams anytime, anywhere.
ICON offers outsourced development services to pharmaceutical, biotechnology and medical device industries. It specializes in strategic development, management and analysis of programs that support clinical development - from compound selection to Phase I-IV clinical studies.
Consolidating and standardizing data from multiple sources such as CTMS, EDC, IVR and ePRO, the new ICONIK solution combines the data with analytical, reporting and visualization tools to provide a single view of study information.
The ICONIK delivers immediate knowledge to study teams by providing near real-time access to study performance metrics, critical safety and efficacy data, as well as analysis of data in new and unique ways.
Offering easy access of study information and trends anytime, anywhere from a secure, web-based interface to CRO and sponsor teams, the new ICONIK facilitates 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.
In addition, the new ICONIK is a 21CFR compliant solution that provides true data transparency and visualization of all study data, from site selection through to database lock enabling clients to view critical safety and efficacy trends as they emerge, said McGrath in a statement.
Furthermore, ICON is the first CRO to completely deploy the Oracle Life Sciences Data Hub, which will form the backbone of the ICONIK Clinical Data Repository, as part of the ICONIK solution.
According to Oracle, the Oracle Life Sciences Data Hub is an integrated environment for - clinical data; improving regulatory compliance; providing better insights for more informed decision making; and improving productivity. It replaces multiple analytical systems with a single integration and reporting system for data integration, metadata management, blinding and unblinding, report execution, report storage and retrieval, workflows, and data visualization for the entire clinical development organization.
The 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 analyzed and reported to support better decision-making, according to a press release.
McGrath added, "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."
Jayashree Adkoli is a contributing editor for HealthTechZone. To read more of Jayashree's articles, please visit her columnist page.Edited by
Rich Steeves
