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etrials™ IVR/IWR
Providing Site Intelligence.
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Overview
Going far beyond traditional interactive voice response (IVR) systems, the etrials Site Intelligence Solution is a powerful trial monitoring and control tool.
Through a single, easy-to-use, Web-based interface, etrials' Site Intelligence Solutions provide dynamic access to clinical site performance, logistics and protocol compliance.
Take back control of your trial
etrials' Site Intelligence Solutions allow sponsors to easily manage site or stratum-based patient enrollment, the compliance of sites and subjects, and what supplies have shipped.
Features
Full integration with etrials' Trial and Patient Intelligence solutions
Advanced dynamic randomization algorithms allow for smaller sample sizes and realize tremendous cost savings (Traditional static randomization is also available)
Supply chain management based on statistical probabilities involving shipping times, expiry dates and enrollment
Real-time views and drill down capabilities which enable ability to manage a trial without having to run a report
Robust import and export capabilities integrate information, regardless of source or system, to assure immediate, easy access to all data
Simulation tools ensure validity, proper randomization, accurate drug supply distribution and eliminate study design inefficiencies
Flexible warning, notification and reminder messages distributed via email, fax, or the Web enable fast response to critical, time-sensitive information
Unblinding capabilities with proper notifications in case of adverse events
Configurable treatment workflow depending on a wide variety of factors including the regime, visit number, site input (for titration) and/or lab results
Role based, configurable user administration keeps users focused and productive
Flow tracing allows sponsors and program managers to review entries and quickly resolve disputed claims
Full 21 CFR Part 11 compliant with comprehensive audit trails that are maintained to meet regulatory compliance and provide a complete history on every data item
Reasons to Buy
Clients that choose etrials' Site Intelligence Solutions can gain:
Site-wide visibility and control through a central interface
Comprehensive drug and supply management
Patient/site enrollment or discontinuance
Site, monitor and patience performance management
Dynamic randomization capabilities
Real-time analysis
Administrative Web Interface
A standard feature for all Site Intelligence or IVR clients, the Administrative Web Interface is a permission-based user-friendly application that enables complete study control and visibility of enrollment, randomization and drug supply management capabilities.
Drug Supply Management
etrials Site Intelligence Solution is the ONLY known IVRS application on the market that automatically identifies which treatment for which patient in a double-blinded study. Depending on the visit, patients on different regimes get dispensed automatically. The system identifies the drug expiration, its location from the supplier and to which sites each drug should be delivered.
Enrollment and Randomization
Visible and controllable directly from the Administrative Web Interface, etrials Site Intelligence Solution automatically gathers patient enrollment demography information, ensuring site enrollment and patient stratifying are defined in relation to patient randomization for optimal balance. The dynamic randomization capability automatically determines optimal balance based on the current study state.
etrials Site Intelligence Datasheet