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Safety data management

Pharmaceutical 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 pharmacovigilance space. Infosys offers a comprehensive suite of pharmacovigilance 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 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
Infosys Safety Data Management solutions  

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