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Analytics and Data Visualization

01

What Pharmaceutical Firms Look For

  • A robust data analytics framework that enables comprehension of patient safety data and extraction of valuable insights

  • 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

  • Assistance with audits and inspections by providing requested data to Health Authorities

02

How We Can Help

  • Demonstrate expertise in providing reporting and analytics solutions utilizing Patient Safety Data.

  • 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

03

Key Reports

  • Standard Safety Search

  • Submission Compliance Report

  • Workflow Monitoring Report and Dashboard

  • CIOMS II Line Listing

  • Signal Detection

  • Tailored Periodic Reports – PBRER, DSUR, PSUR, PADER

  • Comprehensive Case Duplicate Search Report

  • Audit Log Search Report

  • ESM Reports

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