Life Sciences

Oracle Health Sciences Empirica Study on Demand

The Oracle Health Sciences Empirica Study on Demand system integrates data from clinical trials into a CDISC SDTM-compliant data repository and performs automated screening for potential safety issues. It provides an effective means for detecting potential safety problems early in the pre-marketing clinical trial stage.

With graphical, tabular, and statistical tools to assist clinical safety staff in examining, analyzing, and classifying potential signals prior to drug approval, Oracle Health Sciences Empirica Study on Demand enables biopharmaceutical companies to better understand the safety profile of products in development.

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BENEFITS

Enables the reuse of advanced statistical analysis algorithms and simplifies pooling of data, bringing a new degree of visibility into clinical data for safety reviewers
Helps sponsor safety reviewers explore and improve their understanding of the most critical safety concerns that preoccupy regulatory reviewers when examining product licensing applications
Provides a scientific framework for proactive review of the safety profile of emerging products
Supports a more active and transparent safety review process
Provides easily navigable access to clinical trials safety data
Supports analysis of a single study or pooled studies
Allows exploration of demographics, adverse events, concomitant medications, labs, ECG, vital signs, completion, and other study data through interactive visual displays
Enables rapid, online assessment of safety data for routine review, exploratory analysis, and characterization of potential signal