Users can follow this link to access the Evidex login page. If a user is having trouble accessing their account, contact the Evidex Help Desk at helpme@adverahealth.com, by calling +1 (707)-800-3826, or by clicking on the round chat icon in the bottom corner of any Evidex page.
Once logged in, users can access ESM by clicking on the Evidex Signal Management button underneath the universal search bar from the Home screen.
ESM Set Up
To begin using Evidex Signal Management (ESM), the Admin user must first:
Add one or more Products to their module
Assign User Permissions for all users in their organization
If a user needs assistance in assigning their Admin user, please contact +1-707-800-3826 or ademakas@adverahealth.com.
Adding Products - FAERS Surveillance
Once logged in and inside Evidex Signal Management, the Admin user must click on the “Utilities” tab. This will open a page showing the different customization options for ESM. To add a product, click the “Add/Edit Drugs/Products” link at the bottom of the page.
This will open the “Add/Edit Products” menu. Next, click on the blue “Add Product” button.
Next, the Admin user will type in the name of the product as they wish it to appear in ESM. If the user’s organization will be tracking potential safety issues for a clinical-stage product and Evidex is not yet linked to their internal database (i.e. Argus, ArisG, or Veeva), the user can click “Save” and continue to the next section.
If the user’s organization will be conducting their signal detection on Advera’s FAERS data, the user must also type in to search for, and click on to select, the appropriate Evidex drug. Then the user can click “Save” and continue to the next section.
For users with access to the Surveillance – ICSR module, which connects to their Argus, ArisG, Veeva or other hosted internal database, Advera’s technical team will ensure their ICSR products are appropriately mapped during the validation/implementation process prior to user access launch.
For any new products added after initial implementation, the Admin user must begin on the Utilities Products Add/Edit Drugs/Products page. Next, select the blue “Add Product” button and type in the ESM Product Name as user prefers the product to appear in Evidex Signal Management.
Next, type in and select the product(s) from the MCN Products field that will be mapped to the ESM Product Name above. This step ensures that the ICSR data will be pulled into ICSR Surveillance to automate safety surveillance on an organization’s products. Clicking “Submit” will save the ICSR/MCN product to the organization’s Surveillance – ICSR module.
Users then need to select the products they would like to see displayed within the Surveillance – ICSR tab. Users will be able to filter the result set by the products set up in the previous step. If the user’s organization has access to the Surveillance - ICSR Module to connect to their internal database, users can open the report by clicking the Surveillance Tab, and then the Surveillance - ICSR Tab.
Locate the “Options/Settings” menu and click the “Manage Products” menu item to open the product selection modal window.
In the Product Manager window, select the products you would like to see by default in the Surveillance - ICSR result set by clicking the corresponding checkbox in the right-hand column. Changes are saved automatically and will update the result set. This setting affects your entire organization. Click the X in the upper right corner to exit the utility.
Assigning User Permissions
In order for other members of an organization’s team to use Evidex Signal Management, the Admin user must first assign User Permissions. From the Utilities tab, click on “Manage ESM User Permissions”.
Next, click on the name of the User to add ESM permissions.
Click on the Access Type desired for the user, then click “Submit”.
