Evidex Signal Management is a cloud based, software-as-a-service drug safety signal management platform built within the Evidex Data & Analytics user interface. Evidex Signal Management is audit-ready and compliant with Good Pharmacovigilance Practices (GVP) Module IX for Signal Management that allows an organization to track safety signals, inquiries, and other requests from detection through resolution.

Evidex signal management, or ESM, can connect to any number of data sources that users need access to, or can be a standalone signal management system without any connection to your ICSR database, or other data sources.

ESM connects with data sources including but not limited to FAERS, Client’s ICSR database (Argus, ArisG, Veeva, AB Cube, etc.), Vigibase, EVDAS, EDC, Claims, VAERS, etc.

Evidex Signal Management provides a way to:

1) Automate signal detection

2) Serve as a single source of truth for safety signals, as well as drug safety related inquiries and other requests

3) Track all actions that are performed in the management process of signals, inquiries and requests, and

4) Facilitate the workflow necessary around signal detection, validation, prioritization, and resolution in an audit-ready and GVP-IX compliant manner.

The Main Dashboard displays all logged Signals, Inquiries/Requests, outstanding Reviews, and Future Actions Needing Completion.

Inquiries come from regulatory agencies such as the FDA, EMA, etc. that need to be logged, tracked, and have action taken on for resolution.

Requests can capture any other records that do not qualify as Signals or Inquiries that your team needs to have logged in the central repository within ESM. Users can define these in their Standard Operating Procedures, but typically include items such as meeting minutes, changes to Informed Consent Forms, or non-clinical toxicology items, etc.

Management Reviews can be assigned to users for your organization’s periodic reviews, whether monthly, quarterly, or any other time frame you need to set.

Actions are workflow items assigned to members of your team for any existing Signal, Inquiry, or Request. These are tracked within the system, and users will receive email notifications when they are assigned an Action.

See our full video library for tutorial videos on Evidex Signal Management.