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Integrated Signal Management

Record, Track, and Mitigate.

Track and resolve safety signals from any data source with audit-ready and intuitive tools. Fully validated off-the-shelf based on GVP Module IX signal management guidelines. Flexible enough to meet any organization’s unique needs. Fast, compliant, and lean implementation. Integrated and automated signal detection provides a holistic and modern approach to pharmacovigilance.

What's Included

Good Pharmacovigilance Practices (GVP) facilitate the performance of pharmacovigilance. and is broken out into several modules. GVP Module IX - Signal Management (GVP IX) provides general guidance and requirements on scientific and quality aspects of signal management.

Track signals from any data source alongside internal and external inquiries and requests. 

Link signals, inquiries, and requests together for a full view into how an issue is being handled.

Actions are logged to create an audit trail. Future Actions can be created and assigned to responsible persons for an infinitely configurable workflow. 

Seamless integration between signal detection and signal management enable tracking on any dataset. Ability to manually add signals provides for complete flexibility.

Customizable filters and detailed user level tracking ensure regulatory compliance.

What makes our signal management solution better?

tech stack

Built on Web 2.0 technology

Evidex is cloud-native, software-as-a-service built on next generation technology with a best-in-class user interface minimizing resources needed for implementation and providing tools safety reviewers want to use.

 

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Best-in-class customer support

Your Evidex Product Specialist is always available to train new users, conduct refresher sessions, or answer questions on-demand. In-app chat support is available in Evidex as is an interactive, online user guide. 

 

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Off-the-shelf, validated data integrations

Signal detection and advanced analytics on FDA Adverse Event Reporting System (FAERS), WHO's VigiBase, and our proprietary clinical safety database are included from Day 1.  

 

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Ready to take the next step? 

Signal Detection

Advanced surveillance on any data source.   

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Advanced Data Analytics

Uncover hidden patterns, unknown correlations, and trends to become a value-added partner to your organization

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