Safety Data Management

Pharma and Biotech companies are under increased scrutiny by the regulatory agencies to address their drug safety issues as well as re-evaluate their systems and processes for timely reporting while maintaining regulatory compliance.

A comprehensive technology solution is needed to address the challenges in the pharmaco-vigilance space. Infosys offers a comprehensive suite of pharmaco-vigilance solutions under a single umbrella of Safety Data Management solutions targeting drug safety issues.

Features

• The solution offers a web-hosted safety data exchange application combining two different safety databases between partner companies for 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
• Enables early detection of ad hoc and hazardous signals

Benefits

• Based on multi-tier web-enabled architecture for higher scalability and maintainability
• Customer-specific for alignment with clients' existing technology and infrastructure
• Robustness to support company-specific business changes
• Enables compliance with 21 CFR part 11, GCP and worldwide regulations on safety data management
• Provides very high standards of data integrity and security

 

 

 

 

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