Drug Data Safety Management & Pharmacovigilance Services

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