Corpus Application Suite® is a proprietary solution offered by Youweraise to meet all aggregate regulatory and internal reporting needs. Developed using advanced technology, Corpus Analytics® enables the user to query, analyze, monitor safety data and also complements with the reports that are not available in Safety System.
Corpus Analytics
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A plug and play solution compatible with Argus Safety Transactional, DLP, Argus Mart and Argus Insight
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Interactive screens for analyzing and monitoring safety data
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Report generation on point-in time data
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Ad-hoc reporting
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A simple drag and drop (select/unselect) functionality for non-technical users to develop reports
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Pre-configured templates for standard formatting and look & feel
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Report configuration
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Report scheduling
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Email
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Alerts
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Corpus Reports Library
Corpus Analytics® comes with a reports library that consists of 40+ Out-Of-Box pre-configured customizable reports designed to meet 90–100% PV reporting needs. Various reports in report library are categorized as follows:
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Regulatory Reports (PSUR, DSUR, PBRER etc.)
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Supporting Aggregate Reports
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Line Listings
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Linked Cases (Pregnancy and Lactation)
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Lot Manufacturer (Vaccine Reports)
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Device Reports
Corpus Compliance Monitor
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Inspection readiness
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Case processing matrices
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Prospective and Retrospective Compliance Dashboards
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Case tracking in workflow
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Tracking of delays and potential delays
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Capture and track reasons for lateness
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Assign and track action items
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Create, assign and track CAPAs
Corpus Signals
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Safety profile tool for
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Line listings
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Tabulations
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Charts and graphs
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Drill-down, slice and dice
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Comparison/analysis of pre and post authorization data
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Data mining
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In-house safety system
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FAERS, VAERS and Vigibase
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WHO-UMC
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Trend analysis
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Spike analysis
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Reports
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Reaction monitoring reports
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PRR (Proportional Reporting Ratio)
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Benefit-risk reports (Indication vs Reactions)
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Patient demographics
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Drug-drug, drug-disease interaction
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Overdose, abuse, misuse, medication error
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Corpus Topics
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Workflow
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Create assign and review topic
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Create and assign action items
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Annotation, tag (keywords) single or multiple cases
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Add attachments
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History and audit trail
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Reports
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Search on topic or keywords
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Generate and review the listings, tabulations, charts and graphs
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Single case review
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Corpus Risk Management Module
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Develop and maintain RMP and Pharmacovigilance Plan
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Analyze safety data with RMP
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Safety signal evaluation
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Ad-hoc
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Periodic
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Medical Monitoring
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Risk benefit assessment
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Identified risks
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Potential risks
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Causality assessment
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Corpus CAPA Vigilance
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Create/Initiate CAPAs
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CAPA workflow
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Assign/re-assign
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Attach case list
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Add user story
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Attach documents
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Audit trail