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Safety Data Management

Overview

Infosys offers a comprehensive suite of pharmacovigilance solutions under a single umbrella of Safety Data Management solutions targeting drug safety issues.

Robust customer specific compliance enabling scalable Pharmacovigilance solution

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Safety data management

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Features

  • The solution offers a Web-hosted safety data exchange application combining two different safety databases between partner companies. This promotes efficient exchange of safety information on jointly marketed products.
  • Provides a customized web component, building an interface between safety and clinical databases, for online reconciliation of SAEs.
  • Offers a document-control solution for electronic capture of all source and submission documents related to drug safety.
  • Enables efficient reporting of safety information to regulatory authorities in the form of a global submission tool.

Benefits:

  • Based on multi-tier web-enabled architecture for higher scalability and maintainability
  • Customer-specific alignment with clients’ existing technology and infrastructure
  • Robustness to support company-specific business changes

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Challenges & Solutions

Enables compliance with 21 CFR part 11, GCP, and worldwide regulations on safety data management

Offers a document-control solution for electronic capture of all source and submission documents related to drug safety.

Enables early detection of ad hoc and hazardous signals.

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