Safety Database
Drug Safety Monitoring
Qualified Person of Pharmacovigilance (QPPV) Outsourcing
Safety database solutions streamline QPPV outsourcing, enabling efficient monitoring and compliance with drug safety requirements.
Pharmacovigilance System Master File (PSMF)
A well-organized safety database supports the development of a PSMF, centralizing all essential drug safety information.
Risk Management Plan (RMP)
Safety database integration enhances RMP creation, enabling the identification and mitigation of potential risks effectively.
Individual Case Safety Report (ICSR)
A robust drug safety database simplifies the preparation and tracking of ICSRs, ensuring accurate and timely reporting of adverse events.
Periodic Benefit Risk Evaluation Report (PBRER)
Safety database capabilities assist in generating comprehensive PBRERs, evaluating the ongoing benefit-risk profile of medicinal products.
Addendum to Clinical Overview (ACO)
With safety database tools, the development of ACOs is more precise, providing a thorough overview of safety and efficacy data.
Local Display
Drug safety databases facilitate localized safety monitoring, ensuring compliance with regional pharmacovigilance regulations.
Pharmacovigilance Training for Different Levels
Safety database platforms support training programs by offering practical insights into data management at various expertise levels.
Local & Global Literature Screening (Weekly, Monthly & As Requested)
A dynamic safety database aids in systematic local and global literature screening, detecting emerging safety signals proactively.
Standers Operations Procedures (SOPs) Development
Using a safety database, SOPs are developed to standardize and improve processes for managing drug safety information.
Performing Qualification Audits
Safety database functionalities help perform rigorous qualification audits, verifying compliance and strengthening safety operations.