Analytics and Data Visualization

What Pharmaceutical Firms Look For

Robust Reporting Solutions based on a variety of Patient Safety Data Sources
Experience with Third-Party (or Vendor Developed) Reporting Tools
Different Essence of Reports - Operations, Risk Management, Submission Compliance and Aggregate Reports
Assistance with audits and inspections by providing requested data to Health Authorities
A robust data analytics framework that is efficient, validated and audit-proof
Experience with a variety of Reporting and Dashboard Tools
Ad-hoc one time reports and re-usable Standard reports
Report transmission automation and integration with other interfaces
Tailored periodic reports designed for submission to Health Authorities
An analytical solution for monitoring daily case processing activities
Support for ongoing business operations, assisting various departments within Drug Safety

How We Can Help

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.
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.
Proficient in utilizing reporting tools like IBM Cognos, SAP Business Objects, and Oracle OBIEE
Implement highly efficient dashboards using Tableau and Spotfire to present data in an interactive manner for quick and informed business decision-making
Possess a strong understanding of database architecture design for Argus Safety, Insight, and Argus MART
Develop custom reports and standard listings in compliance with the latest Regulatory Guidelines
Conduct requirement gathering, and create user, functional, and design specifications
Thoroughly draft, test and validate reports through Operational Qualification (OQ) and Performance Qualification (PQ)
Prepare user training materials to ensure effective utilization of the reporting system
Establish data extraction processes following the Software Development Life Cycle (SDLC) framework
Update custom periodic reports to align with the most recent Health Authority guidelines

Key Reports

Standard Safety Search
Signal Detection Report
Submission Compliance Report
Workflow Monitoring Report and Dashboard
CIOMS II Line Listing
Signal Detection
Tailored Aggregate Reports – PBRER and DSUR
Comprehensive Case Duplicate Search Report
Audit Log Search Report
ESM Reports