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Evidex 1.44.0 - New Features

Release 1.44.0 includes two major feature launches and a series of site-wide fixes and enhancements.

Andrea Demakas avatar
Written by Andrea Demakas
Updated over 3 years ago

Major Feature Launches:

  1. Signal Detection Plan within the signal management module

  2. Vaccine safety data within the signal detection and signal management modules.

  3. EU Label Status added site-wide.

Signal Detection Plan

Signal Detection Plan Reviews are a new feature on Evidex Signal Management to help conduct ongoing monitoring of signals according to a client’s own Signal Detection Plan. Signal Detection Plan Reviews can be used to automatically schedule and create ongoing reviews on a regular basis using templates.

  1. Client teams can now integrate their Signal Detection Plan into Evidex and receive a reminder when they need to review data on a signal that requires automated monitoring. They can also add comments on any finding/conclusions made during that review.

    1. Multiple signals that require reviews from various data sets (ICSR, EVDAS, FAERS, Literature, etc.) and different periodicities (Daily, Monthly, Quarterly, etc.) can all be seamlessly tracked within Evidex Signal Management.

    2. When the client teams perform this review, they can easily attach case documentation or line listings from all of integrated data sets within Evidex Signal Management.
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  2. To begin, log in with a user account with the appropriate access permissions, click the “Evidex Signal Management” tab from the home screen, then select the ESM Reviews Tab, and the Signal Detection Reviews subtab. This will bring you to the Signal Detection Plan Reviews Outstanding Summary page, which shows the most current or upcoming review for each template.

    1. This page is likely blank if no templates have been created yet. If there are Reviews Outstanding here, users can choose to View Edit History, or Bulk Sign Off on several Reviews at once. You can also use the column header filters to filter the data table by any of the data columns, and export data or hide columns by clicking the menu icon in the upper right corner of the data table.

    2. The first step to create a Signal Detection Plan template is to click “+Add SDP Template”.
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  3. From the Add Signal Detection Plan Template page, the details of the reviews can be specified. This is not the same as performing a review. Actual reviews will be initiated by a scheduled task on the dates specified in this template.

    1. Type in the name of the Signal Detection Plan Review Title.

    2. Next, the schedule of new reviews can be specified using the 'To', 'From' and 'Frequency' fields.

      1. For example, a user could click on the “Frequency” drop-down and select “Weekly”. To create a recurring Review, under the “Recurring” drop-down, select “Yes”. Then specify the date range 4/12/2021 - 4/27/2021 using the “From” and “To” calendar fields, and upon saving the template, a review will be immediately created, and then a second review would be created on 4/19/21 and a third on 4/26/21. After the 'To' date has passed, new reviews will no longer be automatically created.

    3. Users can enter a “Due Date (after period end date)” which will populate the Due Date for the Reviews. For our example, selecting “3” days will trigger each weekly Review to be due 3 days after each weekly due date for the time period specified.

    4. Users can select one or more “Responsible Persons” from their organization. These users will receive email notifications regarding the Review, and reminder emails when Due Dates are approaching or overdue.

    5. Email notifications will be sent to Responsible Persons via esm@adverahealth.com on the Frequency they have selected in the template:

      1. Daily: On Each Due Date

      2. Weekly: 2 Days Before Each Due Date, and Each Day After

      3. Every 2 Weeks: 2 Days Before Due Date, and Each Day After

      4. Monthly, Quarterly, Annually: 1 Week Before Due Date, 2 Days Before Due Date, and Every Day After

    6. Selecting “Product Names” from the drop-down menu allows users to list the product(s) to be included in the Review.

    7. Type in a “Topic” to list the topic of the Review.
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  4. Users can also search for and select MedDRA Preferred Terms or SMQs, list specific Trials that should be reviewed, different Data Sources, and whether to Send Emails associated with this Review.

    1. Additional optional fields include typing in a Trial name associated with the Review, selecting a Data Source for the Reviews to be completed on, and choosing whether Responsible Persons should receive email notifications from esm@adverahealth.com regarding due dates for the Reviews.

    2. Lastly, after completing all Required Fields, users can also add a hyperlink or choose a local file to upload Supporting Documents for the Review. This will attach the document to the Review Profile for the Template. If you are attaching a local file from your computer, ensure that you click the blue ‘Upload’ button after selecting the file to attach it to the Template.
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  5. Clicking the 'Save Template (Populate Upcoming Reviews)’ after filling in all required fields will then bring you to the 'Review Profile’ page. Users with appropriate access levels may edit or delete the template using the 'Edit Template' and 'Delete Template' buttons in the upper right corner of the screen.
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  6. Clicking ‘Show Edit History’ will bring you to the Audit Log for the Review Template.
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  7. Use the “back” arrow on your browser to go back to the Review Profile. This Review Profile page provides a list of current and upcoming reviews as well as a list of completed reviews for a given Template. Only reviews where the start date has elapsed will be able to be conducted.

    1. If a user is assigned to a review, they can conduct the review by clicking the date range for the Review they wish to work on under the first column titled ‘Period Covered’.

    2. This will bring them to the 'Conduct SDP Review' page.
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  8. On the Conduct Review page, an assignee will be able to add any necessary comments/justifications, file attachments, or web links using the 'Add Comment' and 'Add / Edit Documents' buttons.
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  9. Using the “Bulk Attach Documents” button will enable you to bulk attach the document to all reviews of the same frequency. You can select and deselect different Review Titles from the modal pop-up to choose which Reviews to attach the document(s) to.
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  10. Once the assignee is satisfied with the review, they can click the 'Sign Off Now' link in the 'Responsible Persons' section. A modal window will appear that will prompt the user for their login credentials. Click the 'Submit' button to complete the review.

    1. Users of the Evidex 'single sign-on' feature will not be prompted for credentials.
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  11. A list of all created templates can be viewed using the ‘Signal Detection Plan’ link in the fourth row of the tab navigator.

Vaccine Safety Data

In response to the COVID-19 pandemic, Evidex now features comprehensive vaccine safety data incorporated throughout the signal detection and signal management modules.

  1. VAERS data – all historical data from the CDC/FDA’s Vaccine Adverse Event Reporting System (VAERS) is now available in Evidex. VAERS data is processed using the same ML/AI enabled processes for optimization, clean-up, and de-duplication that are applied to other datasets available in Evidex. VAERS data contains information on 111 unique vaccines, including all of the COVID-19 vaccines. VAERS data is updated to Evidex weekly.
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  2. Vaccine Clinical Data – we have initiated coverage of clinical safety data for 71 vaccines, including all of the COVID-19 vaccines. Like with our drug clinical safety database, we have extracted key safety outcomes from ClinicalTrials.gov. Having access to these data enables signal detection across the clinical development process and into post-marketing. Having access to the clinical data will bolster signal detection and management being done on spontaneous and internal vaccine safety databases.
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  3. Vaccine signal detection functionality – vaccine data is now available on standalone vaccine profile pages, vaccine-AE pages, and detailed case profile reports. In future releases we expect to add additional reporting and visualization reports along with custom queries.

European Drug Label Coverage:

Evidex has included drug-event label status as an out-of-the-box functionality for a number of years. With release 1.44.0 we are expanding that coverage to include EU label status. The label status will improve signal detection work flow and algorithms by alerting clients whether a particular event seen in the spontaneous or ICSR databases is already on the EU label and/or potentially a disease related event. At launch, Evidex will include comprehensive coverage of 847 EU drug labels and the data is updated on a regular cycle along with the US label coverage.

Minor Fixes and Enhancements:

Evidex Signal Management

  1. ICSR Surveillance, DEC Summary – Added hyperlink to “Cases” and “New Cases” that links to Case Review:

    1. From Surveillance tab in Evidex Signal Management, click on ICSR – DEC Summary.

    2. Under the “Cases” column for an adverse event, click on the number.
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    3. You will be brought to the Case Review tab with cases filtered by the given drug and adverse event.
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  2. Added a section for linked documents to Completed Actions table within an existing Signal Detail Report:

    1. Click on the Signals Tab within Evidex Signal Management.

    2. Click on a Signal ID

    3. Add a Completed Action with required fields filled out. Attach a local file to the Action and click Save.
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  3. Setting Signal status to 'Closed' populates 'Closure date'.

    1. Click on the Signals Tab within Evidex Signal Management.

    2. Click on a Signal ID. Click “Edit Signal”.

    3. Under the Status drop-down, select “Closed”
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    4. A pop-up will appear asking if you would like to populate the Closure Date with today’s date. Select OK.
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    5. Scroll to the bottom of the form and click “Save”

    6. Signal Closure Date is now populated with today’s date.

ICSR Surveillance

  1. Re-tooled navigation to use new 'sub-tab' 3rd navigation row vs. previous dropdown navigation.

    1. Click on Surveillance tab within Evidex Signal Management. From ICSR tab, click on Case Review 3rd row sub-tab to be brought to that view.
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  2. Add ability to export ICSR Case profile to Management Reviews:

    1. Click on the “Case Review” tab within Surveillance – ICSR
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    2. Click on a Case ID. Under Options drop-down, select Export PDF to ESM
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    3. Search for a “Review” within the “Attach to Existing ESM Record” box and select a Review. Click Submit to attach the case to the Review.
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    4. Scroll down to “Supporting Documents” section and see the attached Documents from Case Profile.
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  3. Added hyperlink to ICSR data from attached Signal/Inquiry/Requests:

    1. Click on the Signals tab within Evidex Signal Management and click on a Signal ID.

    2. Products with ICSR data will display a hyperlink next to the Preferred Terms ICSR section.
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    3. Clicking the blue hyperlink will bring users to the Case Review page with the cases filtered for the given Preferred Term and Product.

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