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The Future of PVOPs Management

Establishing the capability to take informed decisions with well-orchestrated pharmacovigilance processes and unified communication will be a market differentiator for sponsors and affiliates.

To stay compliant with evolving safety and pharmacovigilance global regulations while working with multiple vendors, business partners, affiliates and service providers, sponsors are increasingly working towards developing risk-based operational intelligence with integrated and insightful digital PV process management.

PVSentinel is a process orchestration and compliance governance solution to streamline, track and manage different PV operations and cross-functional activities involving Market Authorization Holder, Business Partners, Affiliates and Vendors.

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PVSentinel Application Modules

Clients can choose to opt for one or application modules in varying combinations according to their business need. The PVSentinel SaaS subscription has a flexible pricing model benefiting organizations to scale-up operational efficiency.

IRT with Mailbox

L2A Case Management

Agreements (SDEA)

Exchange and Reconciliation

Aggregate Reports

SUSAR Distribution

Electronic PSMF

Literature Screening

Audits and Inspections

XEVMPD Management

Social Media Monitoring

ICSR QA

Agency News

Key Platform Components

Following are few of the key platform components which enable operational oversight and compliance management across various PV Operations:

  • Process Alerts & Notifications
  • Integrated Email Inbox
  • PVOps Business Intelligence Studio
  • Process Automation
  • Audit Trail & Utilities
  • Cross Functional System Integrations
  • Business Workflows
  • Digitalization of content
  • Collaboration on tasks and activities
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What do we offer clients with PVSentinel?

  • Fast track safety system implementation with 4 system environments
  • Proprietary accelerators for rapid application configuration setup
  • PVSentinel is pre-validated with IQ/OQ and is UAT ready
  • Expertise for setting up PVSentinel system integrations & business reports
  • 24×7 Service Desk for Cloud and Application Support
  • Offered with 99.9% Cloud Availability & Disaster Recovery
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