Aardvark released exploratory data from its stopped Phase 3 HERO trial in Prader-Willi syndrome after FDA lifted the hold, and plans a redesigned Phase 3.
|Articles|June 20, 2011
ICON Announces ICONIK
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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 standardizes data from multiple sources, including CTMS, EDC, IVR and ePRO, and combines the data with analytical, reporting and visualization 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.
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 analyzed and reported to support better decision-making.
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