This brief provides early insights into the upcoming 18.4 release of Oracle’s goBalto Analyze. All features are subject to change upon release. We’ve included the following sections:
- Permission-based study view
- Account Metrics Dashboard
- Adoption and Compliance Dashboard
- All Activities + Notes Report
- Contract Module Status Dashboard
- Documents and Submissions Report
- Milestone and Scheduled Activity Report
- Open Activities Report
- Study Startup Industry Benchmarking Dashboard
- Study Summary Dashboard
- Updated views
- New fields
- Service notes
- Technical information
Permission-based study view
For the following reports, Analyze users will now view only those studies that they have permission to view in Activate:
- Study Summary Dashboard
- Documents and Submissions
- Regulatory Submissions and Approval Status
- All Activities + Notes
- Open Activities
- Milestone and Scheduled Activity Planning
- Delivery Dashboard
- Contract Module Stats
- Site IP Release Package Dashboard
Account Metrics Dashboard
We’ll add new columns and filtering options to the Account Metrics export worksheets.
The Studies Details sheet will include:
- a new column and filter for Phase
- a new filter for CRO ID
The Sites Detail sheet will include:
- a new filter for Study Name
- PI Name column (to replace the separate PI First name and PI Last name columns)
- Site Number column (to replace the Site name column)
- a new Site Number filter
All worksheets within the Account Metrics Dashboard will also be updated to reflect current Analyze standard report branding for line graphs, bar graphs, and tables. We’ll also remove blank spaces between fields in the Studies Dashboard.
Adoption and Compliance Dashboard
We’ll make the following enhancements to the Compliance section of the Adoption and Compliance dashboard:
- Add IP release milestone completed date to the site IP release status compliance drill down KPI
- Add days in activation to the site activation compliance KPI
- Add days since last activity completed to the site activity compliance KPI
All Activities + Notes Report
The report’s All Notes worksheet will distinguish between general site notes, general country notes, and general artifact notes that are not associated with an activity. These notes will be labeled with an identifier for the user to understand the note type. For general artifact notes, we’ll add a new “Current Artifact Note” filter with an enable/disable option.
Contract Module Status Dashboard
We’ll add new columns to the dashboard’s table section to show the party responsible for completing the next activity on a contract or budget. The columns are:
- With Site - number of contracts with the site
- With Sponsor - number of contracts with the sponsor
- With CRO - number of contracts with the CRO
A new “Contract Location” filter on the Contract Module Activity worksheet will allow users to view a data subset by Site, Sponsor, and CRO.
The Contract Module Activity worksheet will show the status and percentage complete for each contract in two new columns. The new % Complete column will show the percentage of completed activities, calculated as number of activities completed divided by total number of activities created. The Contract Status column will include one of several standard statuses (e.g., Not started, In negotiation, Fully executed, etc.).
We’ll also added a new Site Budget Details Dashboard sheet to provide detailed budget information across an entire study. The new dashboard will allow users to evaluate budgets per site and total expected patient enrollment.
Documents and Submissions Report
To help users quickly see how each site is progressing on the completion of all artifacts, the Documents and Submissions report will include a percentage indicator for artifact completion. The new “% Artifacts Completed” column displays the percentage for total number of artifacts completed divided by the total number of artifacts created for that site. The column will be affected by all filters, with the percentage dynamically updating based on how a user subsets the data with filters.
Milestone and Scheduled Activity Report
To provide more information about study status, Analyze users will be able to view submission status alongside milestones in the report. Only those submissions that are visible on the Activate country or site timeline will be included in the report.
Also note, with release 18.4, the report title will be updated to better reflect the new content. The new title will be: Milestone and Submission Planning.
Open Activities Report
To help Analyze users better understand the full amount of remaining work, we’ll add a new "Role Assigned" filter to accommodate viewing and filtering of unassigned open activities. The filter will allow users to select a value of All, Yes, or No.
Study Startup Industry Benchmarking Dashboard
The Study Startup Industry Benchmarking Dashboard will have several enhancements with release 18.4.
Contract cycle time
Users will be able to easily compare internal contract execution cycle times to industry benchmarks. We’ll add “Site Contract Started to Site Contracted” as a key cycle selection option on the report card and cycle analysis sheets and a new “Site Contracts Started to Contracts Executed” column to the data export worksheet.
Therapeutic area may be entered into Activate with slight differences between users and customers. To account for this, we’ll group similar Therapeutic area values as necessary to account for misspellings or other variability.
Similar to the updates made for Therapeutic areas, we also logically group similar Phase values to account for misspellings or other variability. Phase will also be added as a filter in all worksheets.
The Cycle Analysis worksheet “Slice Your Data by” filter will include an “All” option to allow users to view all their data in one single box plot, and the industry benchmark star will be the median of all data in Activate.
Study Summary Dashboard
The Study Summary Dashboard will have enhancements that allow users to compare milestone progress and see tasks that are falling behind and overall remaining work. Top level Key Performance Indicators (KPIs) percentages will allow comparison of up to four milestones at one time at either the country or site level and will show % planned to actual and % actual to total.
The dashboard’s bottom trend chart will show the overall trends of baseline, planned, or actual dates with a color coded baseline, planned, and actual bar chart. Trend dates will default to display actual, and users can optionally add baseline and planned dates for comparison.
On the Study KPI worksheet, we’ll add a new Baseline bar graph next to the Planned bar graph to allow for easy comparison. We’ll also increased the overall size of the trend chart and add a legend below the trend chart.
We’ll update the account_user_system_roles view to include new Activate role-based permissions introduced in release 18.4.
With release 18.4, Analyze will be updated to include the following new fields:
The Milestone and Submission Planning, Open Activities, and Resource allocation workbooks will have performance improvements to reduce refresh time.
With release 18.4, we will retire the following reports:
- Admin & Compliance dashboard - all previous functionality contained in the dashboard is available in the Adoption and Compliance Dashboard and Account Metrics standard report.
- Release Package Review report - all functionality from this report is available in the Site IP Release Package dashboard.
To increase the performance of highly used workbooks, if a workbook has not been viewed in over 90 days, the extract associated with that workbook will be automatically disabled. If a workbook has not been viewed in over 90 days, the workbook will automatically move to an Oracle goBalto accessible Archive folder. The workbook can be moved back to its original location upon customer request.
The list of supported browsers has not changed with this release. For details, see the Browser support article.
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