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 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 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