A structured, integrated, and deliverable centric process, supported by a stable and controlled application foundation, assures an accurate and auditable data pathway for clinical information flowing into electronic regulatory submissions – A true productivity enhancer.
eNalyze SCE lets users examine, validate and analyze the data while maintaining a complete audit trail of the analysis and reports. Its collaborative fundtionalities bridge the link between a statistical programmer/analyst and a statistician in real-time. An integrated clinical reporting environment with statistical analysis plan facilitates quick production of reports, their validation and review. Its point-and-click mechanism not only facilitates rapid reports production but also automation of standard reports.

eNalyze SCE
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ensures reusability, reliability and transparency across the processes
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helps in building and maintaining a centralized information repository of statistical programs, methods, reports and associate data along with the control panel necessary to take full advantage of the repository. This control panel offers metadata management, data visualization, data validation and analysis - all operating within a secure, web-based software platform that facilitates true collaboration and offers role-based user access with the required traceability.
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facilitates integration of statistical analysis plan and generation of standard clinical reports and clinical study report, along with the support to direct publication of reports from the statistical computing environment to the electronic submission folder (eCTD-M5) for regulatory submission.
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streamlines research operations, reduces costs and time-to-market, and helps identify new revenue opportunities. It empowers researchers to make timely research decisions with complete confidence.
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facilitates execution of traditional and even adaptive clinical trials by facilitating interim reports scheduling, producing & sharing interim reports in a secured collaborative environment, and also optimizing the time between stop-start recruitment during interim analysis.
A Standardized, Centralized Repository - eNalyze SCE provides transparency across all factors pertaining to a clinical study. Utilizing integration adapters, it integrates data from all relevant sources in a standardized, centralized repository.
A truly Collaborative Environment - eNalyze SCE makes all research content readily available for distribution and review. Research scientists and less technical users have direct access to research data, statistical results and all other relevant clinical research content via a secure, user-friendly interface.
Full Compliance - eNalyze SCE meets with all existing and emerging government regulations, including 21 CFR Part 11, as well as good industry practices and sound business methodologies. In built processes monitor audit trails, traceability of data and deliverables, and produces user-friendly reports automatically with a mechanism of auto-escalation via various delivery mechanisms such as email, mobile text message etc. eNalyze SCE is compliant with CDISC standards.