Analytics and Data Visualization
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What Pharmaceutical Firms Look For
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Robust Reporting Solutions based on a variety of Patient Safety Data Sources
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Experience with Third-Party (or Vendor Developed) Reporting Tools
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Different Essence of Reports - Operations, Risk Management, Submission Compliance and Aggregate Reports
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Assistance with audits and inspections by providing requested data to Health Authorities
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A robust data analytics framework that is efficient, validated and audit-proof
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Experience with a variety of Reporting and Dashboard Tools
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Ad-hoc one time reports and re-usable Standard reports
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Report transmission automation and integration with other interfaces
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Tailored periodic reports designed for submission to Health Authorities
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An analytical solution for monitoring daily case processing activities
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Support for ongoing business operations, assisting various departments within Drug Safety
02
How We Can Help
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Merakee BI consultants have great expertise in designing Patient Safety Data reporting and analytics solutions utilizing a variety of safety data sources like Argus Safety, Argus Insight, Argus MART, ARISG and LSMV. This covers the broad aspect of reporting on Live Transactional data, Locked data (data until last ETL time) and point in time data retrieval.
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Merakee BI consultants also have past experiences working with third-party (or vendor specific) reporting tools and also possess the technical capability of learn newer reporting tools and train the end users for efficient use of such tools.
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Proficient in utilizing reporting tools like IBM Cognos, SAP Business Objects, and Oracle OBIEE
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Implement highly efficient dashboards using Tableau and Spotfire to present data in an interactive manner for quick and informed business decision-making
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Possess a strong understanding of database architecture design for Argus Safety, Insight, and Argus MART
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Develop custom reports and standard listings in compliance with the latest Regulatory Guidelines
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Conduct requirement gathering, and create user, functional, and design specifications
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Thoroughly draft, test and validate reports through Operational Qualification (OQ) and Performance Qualification (PQ)
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Prepare user training materials to ensure effective utilization of the reporting system
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Establish data extraction processes following the Software Development Life Cycle (SDLC) framework
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Update custom periodic reports to align with the most recent Health Authority guidelines
03
Key Reports
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Standard Safety Search
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Signal Detection Report
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Submission Compliance Report
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Workflow Monitoring Report and Dashboard
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CIOMS II Line Listing
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Signal Detection
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Tailored Aggregate Reports – PBRER and DSUR
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Comprehensive Case Duplicate Search Report
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Audit Log Search Report
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ESM Reports