Prelude Dynamics Releases Latest VISION Software Upgrade

Prelude Dynamics Releases New Software Version: VISION 10.0 – Exceptional User Experience and Industry-Driven Enhancements 

Prelude Dynamics, LLC, has recently announced the release of its latest software upgrade, VISION 10.0. The new version includes many new features in Composer, VISION’s do-it-yourself study builder, including enhanced usability, additional form logic and bulk editing capabilities for a more efficient study build experience. Monitors will enjoy the new risk-based-monitoring tools and streamlined report creation. As the #1 Electronic Data Capture (EDC) software in animal health, Prelude Dynamics offers a premium EDC solution for both human and animal clinical trials at affordable pricing. VISION 10.0 simplifies data monitoring practices, streamlines study cycles and accelerates approved submissions to the FDA and the Center of Veterinary Medicine (CVM). As quoted from Richard Tieken, the President of Prelude Dynamics,

Prelude has been advancing the conduct of clinical trials internationally with automation for 15 years. VISION 10.0 continues the excellence and has included significant improvements to fulfill the needs of our Full-service and DIY clients.  We know what Data Managers find useful, because we also do that job!  Our clients see results that ease building, managing, and submitting clinical data to FDA/CVM and EMA, and our clients should see even more successful submissions with VISION 10.0.

With this release, users can expect significant functionality enhancements to data capture, data analytics, and data exportation within an improved and friendlier user interface that is also more optimized for mobile-device and offline data capture. Some note-worthy enhancements include:

  • Form libraries to save and re-use forms from past studies
  • Automated invoicing functionality by site
  • A new two-way lab interface with Marshfield Labs that enables automatic submission directly to the lab without manual intervention from the sites
  • Improved AE and ConMed dictionary coding capabilities
  • Enhanced export capabilities including CDISC export format and greater data format configurations
  • A built-in risk-based monitoring tool that highlights the most critical fields in the study as it progresses (AI driven)

Tommy Jackson, COO at Prelude Dynamics, is excited for the release,

Efficiency and compliance are top of mind to every sponsor and CRO with whom we’ve interacted. The enhancements to VISION Composer were specifically designed to address these demands. We are excited for clinicians and data managers to be introduced to an affordable EDC alternative with the same or greater level of functionality and compliance than they are used to.

Focusing on a seamless user experience, Composer offers a fresh new look and reboot to its graphical user interface (GUI), now enabling form building and study schedule assembly all in one central place. Building, copying, and organizing study forms is now easier than ever with a form library that collects previously-built forms and stores them for use in future, per-client Composer studies. Site invoicing, a feature previously only available in the full-service version of VISION, is now configurable within the tool and a new standout feature that tracks site payments and study milestones within the DIY tool. This is just one of the multiple customizable features and functions to be expected in this year’s product release. Prelude Dynamics is focused on the future of animal and human health clinical trial advancement, leveraging industry-driven software updates to its EDC platform and enabling clients to build and configure faster, more complex study protocols in one encompassing product platform with greater data accuracy.

VISION™ Dashboard: The Future of Study Monitoring is Here

With the newest advancement of VISION’s Dashboard tool, monitoring your study or trial has never been easier or more adaptable! With more monitoring capability located in one place, you have the power to review what you need at a glance and dive deeper for further review.

Gone are the days of scattered summaries and reports. With the updated Dashboard you can now monitor what you want, when you want and all on one page with data summaries that you control. At Prelude Dynamics, we understand the importance of quick, convenient monitoring that you don’t have to dig for and in this article we’ll showcase some enhancements to the Dashboard that give you exactly that!

Similar to a news feed, VISION’s Dashboard enables you to decide what data criteria you want to see. No matter what your data monitoring preferences are, we give you full control to arrange and filter your data within the dashboard to your needs while also including fundamental tracking tools like a Quick Stat overview, messaging module, and a built-in study calendar. Real-time data reports and summaries are now all conveniently located in one place – the VISION™ Dashboard.

To access the Dashboard, simply click the dedicated Dashboard icon in the main navigation while logged into VISION™:

When you first arrive you’ll be prompted to take an automated tour of the new dashboard features. One new feature is that your dashboard is fully configurable to show you the data that you need to monitor. You can choose from a variety of summaries, graphs and charts, display the ones you want, hide those you don’t and sort them in any order. Just click the +/- icon to show a list of active and disabled summary modules. Any module you want to view, simply drag it into the “Active” column, click Save and you’re done! Your dashboard is customized and you are ready to monitor.

The Dashboard has 3 Main sections: Overview, Messages and Calendar…

In the Overview section, the Quick Stats module lets you select from important monitoring data counts, like: number of adverse events, serious adverse events, monthly enrollment, number of unresolved queries or total queries, form status data and more. You can then add numerous charts and graphs showing at-a glance visual representation of various data within the study.

Within Overview, you decide which data points to monitor and in what order they are displayed. For a more detailed breakdown on any of the summaries, simply click on the label to access additional information which will display within a table or chart.

In the Messages section, notifications are conveniently displayed in a list so you can quickly review sent or pending notifications, acknowledge them or even compose new ones. The list can also be filtered by category such as adverse event, new patients enrolled, queries, protocol deviations and more to show you only what you want to see.

In the Calendar section, you get a view of the current month showing personal, site and study created events that are color-coded to help keep track of each. You can navigate to view past, present and future months, add and schedule new events and filter them by type to focus on only those events that are relevant to you to help plan and schedule accordingly.

As a Monitoring tool, the Dashboard is a comprehensive one-stop shop. You can pull in any existing subject, site or user summary or any ad-hoc report that you created. This provides you with the ability to view all the important study data in one place, and eliminates the need to click through reports and summaries in separate locations.

It gets even better! You can now also filter the dashboard by a given site or view data for all the sites as a whole. Each report and summary can be filtered separately by any custom search you create. If you want to see only data for enrolled patients, select that filter. Create new reports and filters at any time and they become immediately available for use in the dashboard. You can even pull in shared reports and searches from other users.

That’s a quick dive into our enhanced Dashboard monitoring tool available for all studies with our newest version of VISION™. At Prelude, we believe in the power of convenience, configuration, and time-saving tools for you and your team. Welcome to VISION™ Dashboard!

VISION™ Tips & Tricks: Utilizing Summaries


Did you know that each VISION™ study comes with a set of standard Summaries?  They aggregate Subject and Site-level data, enabling faster monitoring and data validation. Standard Subject-level summaries may include Subject Status, Form Status, Query Details, and Comments (Note to Field).  Standard Site-level summaries may include Site Status, Enrollment, Form Status, Queries and Comments (Note to Field). Custom summaries are also available upon request (and include, but are not limited to Adverse Events, Deviations, Note to File, etc.).

 

To access a Subject or Site Summary, navigate to the Subject or Site list page and Click the “Summaries” button in the footer of the page.
Summaries
Also, please note that if any Searches or Filters have been applied, the Summary data will only display the filtered data set. At the Subject level, you can view Summaries for all sites, or a specific site by specifying in the site dropdown (see Figure 1).

Figure 1. Site selection dropdown can be found in the page header.

You can then narrow the scope of the subjects you’re viewing by applying search criteria (see Figure 2).

Figure 2. Adding Search criteria can help narrow the scope.

See our Tips and Tricks on Layering Data Searches for more details on applying search criteria.

Below is a table of examples found in VISION™:

Summary cohortSummary dataDescription of Summary
SubjectSubject Visit StatusShows the most important dates per subject. (Study visit dates, study completion dates, etc.)
SubjectForm StatusShows the # of forms in-work, in-review, reviewed, finalized for each subject. Also shows the # of unresolved, resolved and reviewed queries per subject.
SubjectQuery Details Summary contains two sub-tabs, one for "Unresolved Queries" and one for "All Queries." Details include subject ID, form/field query was entered on, date, who entered the query, the query, and the time it took to resolve the query (or the time it has been open).
Subject and SiteNote to FieldShows an aggregate of the notes made to subject (or site) fields
SiteSite StatusShows aggregate enrollment by gender, screen failures, and completed study status. It can also display Form and Query status.
SiteEnrollmentShows a graph and/or table of expected versus actual enrollment per site.
SiteQuery GraphShows total versus unresolved queries. Excellent for a quick view of query status overall and for site comparison.

Please contact your Prelude Project Manager for more details or questions on this article.

VISION™ Tips & Tricks: Layering Searches & Reports

Do you want to view only those Subjects who have been randomized?  Do you also want to only view those Subjects who are of a certain age? The VISION™ Search function is a great way to filter data during your study and multiple searches can be applied to your data! Additionally, Reports can be run on top of applied searches (or already filtered data).
You can navigate to the list of study Subjects and click on the “Search Subjects” button. Any form and field you have access to will appear in the drop-down list to be selected. You can set up as many search criteria as needed, keeping in mind that the criteria must all be met for the search to return any results. You have the option to search for Subjects that meet all criteria by using the “And” radio option. Alternatively you can find Subjects that meet at least one of the criterion by selecting the “Or” radio option.

Figure 1. Displays the Search user interface.  You can add as many search criteria as needed using the drop down selections.  Please note you can also select whether the criteria should work as an “And” or an “Or.”  (And = the results must meet ALL the criteria listed; Or = the results must meet at least one of the criterion.)

Upon clicking the “Apply” button at the bottom of the Search Subjects page, the results, if any, will populate on the Subject list page. Once that search has been applied, go back to Search Subjects and add a new Search and enter new criteria. Click “Apply” again to apply the new criteria on top of the previously applied search, further filtering the Subject population. The layering of searches will always operate as an “or”, meaning that results will be returned if it meets Search 1’s criteria OR Search 2’s criteria.
Any applied Search or Searches can also be layered with Reports. After applying your search(es), click on Reports. The Report results will only display those Subjects that were part of the Search results. Questions? For more information on this and other EDC & CTMS solutions please contact us.

VISION™ Tips & Tricks: Viewing Subject Form State Details

Do you know you can view a Subject’s (or Site’s) forms and their status (aka. Form state) at a glance? Navigate to the Subject List Page. For any given Subject, click on the plus/minus (+/-) icon next to the Subject ID field (see Figure 1). The above is also applicable for Site-level forms!

Figure 1. Displays expanded list of Subject ATL-012-IUM Forms.

This will show this Subject’s listing of applicable forms, if any of those forms have Queries (and the status of those queries), and the *Form State of the forms. Additionally, hover over any of the form icons to view the specific form’s title, form state/status (see Figure 2).

Figure 2. Displays tool tip for the first form within the “Screening” form group. Vitals/Phys Exam has a form state of In-Work and has errors that the user should resolve.

*Form States are used to determine the state of the form. The form icon is color-coded to indicate the status of that form.

  • Blue = In-Work
  • Orange = Submitted for Review (User has signed the form)
  • Yellow = Reviewed (User with appropriate privileges has reviewed the data on the form)
  • Green = Finalized (User with appropriate privileges has finalized the form- edits can no longer be made to the form unless a user with appropriate privileges revers the finalized status)
  • No color indicates that the form is “new” and no data has been entered.
  • A Red form icon indicates that there is an error(s) on the form that must be resolved before the user can Submit for Review.

VISION™ Tips & Tricks: Running Reports on On-Demand Forms

Ever wonder how to run reports for *on-demand forms? Wonder no longer! Navigate to the Subject List Page (or Site if running the report from there), click the Reports (see Figure 1) button towards the bottom of the page.
Reports

Figure 1. Reports button

Select the forms and fields you would like to see in the Report. In this example, I am pulling the Subject ID and the Unscheduled Visit date(s). Figure 2 displays the on-demand Unscheduled Visit forms- this example has two of them.

Figure 2. on-demand Unscheduled Visit forms

For an on-demand form (Unscheduled-Vitals/Phys Exam), you will see an extra field appear next to the form name- this is for the form “number.” You can enter 1 to x, depending on which on-demand form you’d like to view data from. Conversely, you can leave it blank which will pull data from all available on-demand forms.

When pulling from all on-demand forms, if more than one form exists, the data will list out within one cell (see Figure 3).

Figure 3. The Visit Exam Date fields from ALL of the Unscheduled Vitals/Phy Exam appear for Subject ATL-003.

*What’s an on-demand form?

On-demand forms are those forms that can be added as required. The first form is always available and subsequent, identical forms can be added as needed. Common examples of these are unscheduled visits, daily assessments, and serious adverse events forms.