Marketing authorization holders / product approval holders and sponsors have to meet ongoing, ever-changing regulations in the field of safety reporting. The considerable functional needs and complexities of safety data management and reporting obligations require a system that is capable of handling the complexities involved in individual and periodic/aggregate reporting, while complying with international regulatory guidelines.
Traditionally most companies have implemented systems in-house and as safety-reporting obligations shifted rapidly, companies were often faced with a continuous cycle of costly upgrades to meet the latest compliance needs. Today the majority of life sciences companies are now looking to implement cloud-based solutions to reduce the burden of compliance and lower total cost of ownership, with the supplier taking ownership and accountability for the entire platform.
LifeSphere Safety MultiVigilance™ - The Only E2B(R3)-Compliant Safety Database
LifeSphere Safety MultiVigilance provides best-in-class core case management for a modern, multi-tenant cloud-based pharmacovigilance system that incorporates advanced technology such as cognitive computing and machine learning to automate the repetitive and routine manual tasks in case processing. ArisGlobal has defined the Industry Standard Platform (ISP) to offer an out-of-the-box standard configuration that, together with LifeSphere services methodology, enables ‘go live’ rapid upgrades and migrations within weeks.
With a robust feature set embodying over 25 years of pharmacovigilance experience and best practices, LifeSphere Safety MultiVigilance provides a single-global database capability for truly global safety case reporting. Multi-lingual capabilities are provided at the database and user-interface level, and the system offers comprehensive and configurable workflow and reporting rule capabilities for all sizes of life-sciences companies and regulators. A fully Japanese language-enabled system is available.
LifeSphere Safety MultiVigilance handles both clinical safety cases, including SUSARs, and post-marketing safety cases. A fully configurable case processing system, LifeSphere Safety MultiVigilance supports data entry compatible with both the E2B(R3) and E2B(R2) standards. The system provides all the tools for efficient case processing including case entry, medical coding, quality control, medical assessment and expedited reporting, tracking all communications and follow-up activity. Expedited and periodic reporting capabilities including PBRER, PSUR and DSUR are included with full workflow monitoring, KPIs and metrics available directly on the dashboard to ensure compliance.