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PVSentinel Aggregate Reports

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Synchronize and Simplify Drug Safety Aggregate Reporting

Marketing Authorization Holders (MAH) are expected to prepare and submit aggregate safety reports to regional and global regulatory bodies to account for the medicine’s safety profile over an extended period of time. These periodic reports shall be used for assessing the risk-benefit of the product and taking appropriate action where new risks or changes to known risks are identified.

PVSentinel Aggregate Reports

With PVSentinel Aggregate Reports, pharma companies can automate the complete regulatory reporting lifecycle management from pre-approval to post-approval of medicinal products.

It facilitates digital authoring of different types of aggregate reports, online completion of collaborative review and creating a reporting schedule for different regulatory submissions.

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Key Product Features

  • Report Schedule Management:Create and Manage global reporting schedules/timetables with calendar trackers.
  • Modular and Templatized: Leverage individual modules and templates to rapidly tailor Aggregate Reports
  • Digital Authoring: Author reports within PVSentinel without any dependency on third party apps
  • Collaborative Review: Schedule, initiate, and complete report content review with multiple teams and reviewers at the same time
  • Workflow driven activities: Define and configure workflows from scheduling, authoring till submission
  • Regulatory tracking: Acknowledgements received for each submission and amendment can be tracked and reported
  • Access Control: Define controls to who can view, edit, review, approve aggregate reports
  • Version Controlled: Access latest version of aggregate report with archived older versions
  • Auto Update Rules: Auto update modules, templates, schedules and aggregate report based on rules defined
  • Sharing: Share aggregate reports in various formats word, PDF, weblink, through various channels
  • Alerts & Notifications: Get alerted and notified on workflow tasks assignment, workflow tasks and related activity updates
  • Insights & Analytics: Ready to use and extendable dash boards, performance indicators

Seamless Integrations with various source systems to enable 100% process automation

  • Drug Safety Database
  • Signal Management System
  • Clinical Systems
  • Quality Management System
  • Literature Screening
  • Other modules of PVSentinel
  • Other organization wide operational data source systems

Aggregate Reporting is a component of our PVSentinel platform. It can be deployed on its own or in combination with other modules of the platform.

How Do we Deliver

Our technology platform, process accelerators and subject matter expertise enable you with a comprehensive solution to digitalize and automate the entire compliance associated with aggregate reporting. Our solutions are flexible, modular and can be deployed by MAH, QPPV office and CRO companies globally or at local entities.

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