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.
- 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.
- 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