Exciting Updates to the VISION DIY Study Builder!

The VISION 10.8 maintenance release is now available and is being rolled out to live studies. This release includes some much-anticipated enhancements, which were developed to facilitate the experience of both study builders and end users. Let’s look at a few of these in more detail! 

  • Use of images instead of textual labels.
  • IDEXX Labs – configure specific tests for study visit days.
  • Calculation copy feature.
  • Set calculation priority using Drag and Drop.
  • Data encryption at rest.

Use of Images instead of textual labels

Sometimes, a picture is worth a thousand words. VISION now supports the ability to use images to describe data entry fields. End users find images easier to relate to and understand than text, which means they can enter data more efficiently and correctly. These images can also be used in VISION’s ePRO app.

IDEXX study visit lab configuration

Now you can easily configure the lab tests for each study visit using an intuitive interface. This reduces training requirements for sites and increases protocol compliance.

Calculation copy feature

When specifying calculations for a particular eCRF, it is common to have a set of operations that behave in a similar fashion. Instead of building each calculation from scratch, users can now simply copy an existing calculation and then modify it as needed. This significantly streamlines the time required to program eCRF calculations and increases usability.

Set calculation priority using Drag and Drop.

Until recently, calculation priorities were set using an explicit numeric value. Now users can set an “Auto-Prioritization” attribute – which allows calculation priorities to be set to the order the calculation cards are displayed in. This feature helps form builders gain a quicker and more intuitive understanding of the logic used in form calculations.

Data Encryption at rest

All data in the VISION database is encrypted in transit (e.g., over the internet). It’s now possible to specify that data be encrypted at rest – offering an extra level of security for Protected Health Information.

VISION™ Incorporates AI Technology for Monitors

Study Monitors have a lot on their plates. While VISION’s automated data cleaning capabilities make their jobs easier, we thought it be useful to provide them with a tool that would automatically flag database fields that are more “challenging” for sites to complete. Our new AI Monitoring Enhancement Engine (AIMEE) does just that. When monitors are reviewing a form, they can turn AIMEE on with a single click of the mouse and instantly focus on database fields that are historically known to require attention.

A single click of an icon turns on AIMEE.

AIMEE calculates a score for each field and highlights those that require attention.

AIMEE calculates a score for each field and highlights those that require attention.

How does it work? AIMEE learns over time and calculates a risk score for each field on the form, and highlights those that merit further scrutiny. What is this score based on? AIMEE looks across all instances of the form in the study and considers the number of changes, queries, comments, and occurrences of errors and warnings for each field on the form. It uses that information to generate a score, which is intuitively displayed next to each field on the eCRF. Low scores are “good” and high scores are “concerning”.

AIMEE works well in conjunction with VISION’s field-by-field review functionality – which monitors can use to indicate which fields they have already investigated. This in turn lowers monitor workload by helping them avoid duplicate efforts.

Reach out and ask for an AIMEE demo today!

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Prelude’s ePro Mobile App Enhances Patient Data Integrity, Compliance, and Efficiency During Clinical Trials

Of all the effective methods used to ensure subjects complete a clinical trial, our favorite is probably the ePRO mobile application. This ingenious app reduces the need for in-person visits to clinics. And who doesn’t love playing with new apps on their phone?

Both human subjects and owners of animal subjects can download this app (on either iOS or Android devices) and use it to fill in surveys and forms from anywhere. All entered data gets uploaded straight to the VISION database with a fully attributable audit trail. That means wherever your patients have cell service, they can intuitively perform contemporaneous data entry. The ePRO app offers a huge advantage over having to wait for a visit or telephone call with the clinic in order to relay daily or weekly observations. Now subjects and owners can don’t even have to get dressed or get in their cars to participate in a clinical trial anymore. Finally, a data management solution for the Netflix and Chill generation!

The ePRO app reduces the loss of subjects who do not want to risk their health by coming into the clinic for a checkup. It gives them the opportunity to enter their data into the system before they forget. Sites can even set up notifications for the users to ensure they enter their information within the expected timeline. This in turn ensures data integrity and reduces site follow-up requirements.

Data can be entered remotely using radios, check boxes, dates, times, text boxes, drop-down menus, and visual analogue scales. Images and videos can be recorded and uploaded for uses such as wound healing checks. All this flexibility and ease-of-use makes subjects significantly more inclined to continue their clinical trial participation. It will also continue to be useful into the future for subjects who would normally have a long commute to get to their required clinic.

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Announcing VISION™ eConsent!

Announcing eConsent!

Prelude’s unique eConsent functionality is the latest in a long line of enhancements aimed at eliminating paper from clinical trials. Up until now, most clinicians have obtained owner and subject consent on paper forms that are then uploaded into the system. Now sites can obtain owner and subject consent electronically the same as for any other user signature for the study.Animal Studies

For animal studies, the process for obtaining owner signatures begins with an owner profile added by the site.  The owner then logs on and immediately signs an electronic signature agreement. After the generic agreement is signed the owner is able to electronically sign any study-specific consent forms. Once the subject is enrolled the owner is free to fill in their own demographic information as well as any forms that are required for the study such as a dosing schedule or owner diary.

Human Studies

For human studies, brand-new technology has been implemented to attach the signed consent form directly to the appropriate PDF document. No personal data will be collected about the subject until the informed consent is signed electronically by the subject.

Notifications

The eConsent feature of VISION includes the ability to send (and re-send) notifications to the subject to remind them to sign relevant forms. A notification can also be sent to site personnel to alert them when a form has been signed. The forms can also be provided with multiple language options for studies enrolling non-English-speaking subjects.

Electronic Signature

An electronic signature is a distinctive mark appended to a document for verification. It offers the same validity as an ink signature yet with an even higher degree of contemporaneousness as it also includes the time/date stamp and logged-on user information. It is a safer, faster, and more cost-effective approach for capturing signatures.

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Johns Hopkins Chooses VISION™ for COVID-19 Studies

Prelude Dynamics, LLC, is proud to announce our partnership with Johns Hopkins on three COVID-19 related studies. This new partnership expands on previous collaborations between Prelude and Johns Hopkins in the areas of Traumatic Brain Injury (TBI), multiple sclerosis, and vertigo. Prelude Dynamics’ VISION™ EDC was selected from a field of EDC providers based on advanced system capabilities, our ability to stand up studies in days, and Prelude’s high level of service.

Prelude Dynamics partners with Johns Hopkins on three COVID-19 Studies

Study 1: Plasma Donor Registry

The first study Prelude and Hopkins are collaborating on is a registry of individuals who have recovered from COVID-19 and are candidates for plasma collection. Once donors are qualified, their Human Coronavirus Immune Plasma (HCIP) can be used in the second and third studies.  These follow-up studies are both Phase 2 and will be randomized and double-blinded.

Study 2: Convalescent Plasma as a Preventative Treatment

The second study will investigate the use of convalescent plasma in high risk subjects who have experienced a close contact exposure to a person with COVID-19 but are not yet symptomatic. With an enrollment goal of 150 subjects, the project will study the efficacy and safety of using HCIP as a preventative treatment.

Study 3: Convalescent Plasma to Reduce Complications

The third study will investigate the use of HCIP as a therapy for ambulatory subjects who have tested positive for COVID-19 through an RNA detection test and have at least one symptom. With an enrollment goal of 1,344 subjects, this project will study the efficacy and safety of using HCIP to reduce complications due to COVID-19. In addition to saving lifes, a positive outcome for this trial will mean HCIP has the potential to greatly reduce hospitalization and ICU requirements for COVID-19 patients.

The randomized studies will use VISION‘s integrated Just-in-Time randomization algorithm as well as our sophisticated masking and source data verification (SDV) functionality . Both studies will be conducted in the US from April 2020 through December 2022. We are excited that Johns Hopkins has chosen our VISION EDC for this potentially life-saving work and look forward to successful outcomes!

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New EDC Feature for POC and Phase 1 studies

Prelude announces a new EDC feature that streamlines data entry for Proof of Concept (POC) or Phase 1 studies. Multiple Subject Data Entry allows users to enter data for multiple subjects at the same time using a single form. Users can configure this form at the site level by selecting the subject level forms and fields for entry. Filters can then be used to select a subset of subjects for processing.

Screen shot of Multiple Subject Data Entry

The VISION™ EDC will post the data to the each subjects’ eCRFs once the data entry is complete. The system will also update the audit trail so that the field changes are attributed correctly. If errors or warnings resulted from the data entry, the subject list page can used to quickly identify those subjects and forms.

This feature is very useful when values are collected for subjects in rapid succession e.g., taking everyone’s vital signs or (for animal studies) counting fleas. In such instances, data is typically manually entered on a clipboard and then transcribed to EDC. Transcription typically requires navigating from subject to subject, which can be error prone and time consuming.  Use of Multiple Subject Data Entry eases transcription and facilitates using the EDC as eSOURCE.

The new Multiple Subject Data Entry feature was designed to offer an extreme level of efficiency for users. It is easy to configure and easy to use. Ask your Prelude project manager today about including multiple subject data entry in your next POC or Phase 1 study! This feature in combination with our powerful EDC, CTMS and CDMS functionality truly makes the VISION™ EDC an industry leader.