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PVSentinel ICSR QA

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Achieve 100% Quality Assurance of your ICSRs for full Regulatory Compliance and Process Efficiency

Quality Assurance of ICSRs is one of the most time and resource intensive regulatory requirement. The ICSR QA ensures the collected safety information is accurate and processed adequately meeting regulations. The ICSR Quality often vary from different stakeholder perspective from data completeness to data correctness.

All the Individual Case Safety reports should comply with the quality obligatory for submitting any safety reports to the regulatory.

PVSentinel ICSR Quality Assurance

PVSentinel ICSR QA enables PV departments to automate the complete quality assurance management of ICSRs. Both prospective and retrospective quality checks can be performed to maintain overall compliance towards regulations.

Using this module, the quality team can create and manage review forms specific to business or organization needs based on any agreements between affiliates and vendors. Review managers can assign the schedules and track the completeness on the reviewers performed quality check. The quality scores and outcomes can be viewed and tracked throughout the QA lifecycle.

Key Product Features

  • Configurable Review Forms: organization specific Review forms can be defined that comply by regulations.
  • Review Schedules: Can create the Quality Assurance schedules that auto assign the reviews to the available reviewers.
  • Digital Review: Review within application without any dependency on third party apps
  • Intuitive Review Process: Upon reviewing the system displays various indications that helps to take necessary decision on the quality.
  • Access Control: Define controls to who can review, schedule, take action in various stages of review lifecycle
  • Version Controlled: Access various versions of review report on the ICSR that had follow-ups
  • QA Reports Sharing: Share ICSR QA reports in various formats PDF, Excel through various channels
  • Alerts & Notifications: Get alerted and notified on QA assignment, Due and any updates for schedule
  • Insights & Analytics: Ready to use and extendable dash boards, performance indicators
Business Analysis

Key Benefits for clients

Execute Rapid ISCR QA Review

We can help your organization to eliminate manual processes of tracking the multiple review sheets/forms which are being used today for maintaining your ICSR Quality assurance activities.

Rapid setup of review forms specific to your need using the pre-defined templates.

Gain 100% Digital Review Process

The intuitive review forms guide the reviewers for their action. The spontaneous Review Forms helps visualize the quality of the ICSR during the review process. The Timely alerts and notifications on review activities enables to ensure quality and compliance.

Comprehensive QA Oversight

With a powerful ICSR QA module, your team can easily perform ICSR review within the agreed timelines. There are ready-to-use extendable dash boards which can be configured to show key performance indicators for taking informed decisions.

How Do we Deliver

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

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

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