IBIL PV–Robust Pharmacovigilance System

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The IBIL PV software will support drug safety business processes from an easy to-understand user interface and provide deep and integrated safety functionality with capability to scale to millions of cases and easily align with the available safety and business processes. Besides providing comprehensive visibility into reporting metrics and compliance, it will enable a highly scalable end-to-end safety process offering automated global case processing, periodic reporting, E2B intake and submission, as well as comprehensive reporting and detailed analytics.

We are uniquely poised to help global drug safety and PV organizations to perform better. We have made our solution unbeatable through deep domain understanding, detailed process knowledge and extensive industry experience. Drug Safety Team management can be highly effective with IBIL PV. You can experience your team more productive than ever - highly flexible workflows, tracking and notification mechanisms improve team productivity.

Solution Scope

  • Case intake and management
  • Medical review
  • Case reporting
  • MedDRA integration
  • Compliance with relevant drug safety regulations (21 CFR Part 11)
  • Bi-directional data exchange
  • Smart search feature
  • Flexible workflows
  • Overview of all cases
  • Assigned cases and tasks to users
  • Work list and notifications for each user
  • Progress tracking through audit trails of user actions
  • Workload overview and details
  • Escalation of past due items

Increasing incidence rates of ADR and the introduction of stringent drug safety regulations are some of the key drivers of the global PV market. Maintaining Pharmacovigilance data is mandatory, yet time intensive and costly. Health regulatory authorities such as the US FDA and EMEA (European Medicines Agency) have started emphasizing on electronic submission of ADRs. A robust Pharmacovigilance solution is an industry need which mainly focus on consistent and accurate acquisition, integration and analysis of ADR data.

Key Differentiators

  • Cost effective pharmacovigilance solution.
  • Intelligent automation - drastically reduce the effort of processing adverse events, also enable an AIdriven level of real-time predictive analytics and actionable insight not previously possible.
  • Chatbots with NLP and advanced AI – Intelligent digital assistants to resolve user queries cheaply, quickly and consistently.
  • Track submission deadlines through effective notification mechanisms.
  • Integrated BI solution
  • E2B(R3) Compliant
  • Automatic processing of source documents using OCR
  • On-Premise and Cloud based delivery model.
  • Standardized procedures and definitions (e.g. follow-up and processing of case reports).
  • Multi-tenancy.
  • Localization with minimal customization
  • Direct import of ADR data - support for multiple data formats.
  • Excellent tool for drug safety team management.

Dashboard and Reports

  • Open case summary reports
  • Open action items report
  • Expedited report status
  • Workflow status
  • Reports due soon
  • Personal status
  • Case workload
  • E2B reports
  • Expedited reports
  • Periodic reports
  • Aggregate reports
  • Case data analysis reports