An Integrated Drug Safety Solution
Sparta's drug safety solutions allows pharma and biotech companies of all sizes to reduce product safety risk, achieve compliance, and improve the efficiency of the pharmacovigilance process. They enable companies to accurately record events, MedDRA code terms against industry standard thesauruses, conduct relatedness and listedness/expectedness assessments, and report adverse events to appropriate health authorities.
The solutions are fully compliant with international regulations and guidelines supporting case management, report preparation, and electronic submissions. The electronic reporting capabilities include flexible mapping and configuration to meet the complex and varying requirements of global regulatory authorities.
Benefits of Sparta's Drug Safety Solution
- Tracks and manages the global processing of all drug safety cases.
- Standardizes and streamlines processes for drug safety reporting to drive both operational efficiency and compliance.
- Facilitates compliance with global and local drug safety reporting requirements through flexible workflow automation.
- Supports risk management programs by automating safety surveillance and signal identification processes.
- Increases transparency through automated drug safety alerts and customizable reporting capabilities featuring dashboards and executive overviews.
- Ensures on-time reporting of all cases for time-sensitive and periodic reporting.
- Makes electronic submissions and tracks both paper and electronic reporting via E2B.
- Processes safety cases.
- Performs assessments and adverse event reporting.
- Manages and tracks customer call triage and complaint investigations.
- Handles all aspects of CAPA planning, execution, and follow-up
Drug Safety Processses
Standardize and streamline processes for drug safety reporting to drive both operational efficiency and improved compliance and facilitate compliance with global and local drug safety reporting requirements through flexible workflow automation.