Prelude Dynamics’ VISION™ platform is the only EDC that provides an electronic interface with IDEXX labs – making VISION the preferred EDC in animal health. This interface greatly reduces the errors inherent in manual reporting, which saves clinicians and pet owners time and saves sponsors/CROs money.
IDEXX recently upgraded their Laboratory Information Management System (LIMS) to include some backend improvements as well as a new customer-facing feature that will clarify some aspects of reporting. Prelude and IDEXX developed and conducted a formal validation on this improved interface in a collaborative fashion – ensuring future smooth operations.
Previously, IDEXX provided the following flags with each reported lab result:
- Normal – the result was within normal ranges.
- High – the result was higher than normal.
- Low – the result was lower than normal.
- None (blank) – an observation for which there is no normal range.
An additional flag of “Not Applicable” has been added and is now used for results of “Do Not Report” (DNR) or “Quantity Not Sufficient”, which were previously not flagged. This new flag will serve to alert clinicians when samples should be re-taken (or other appropriate action) and lessen the chance they will overlook these findings and assume they are normal.
Prelude Dynamics and IDEXX continue to be committed to improving the efficiency and accuracy of clinical data and streamlining clinical research.
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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.
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 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.
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.
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.
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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Integrated invoicing is a powerful mechanism for incentivising site participation. It also eliminates extraneous trial management activities. What is it and how does it work? This article takes a closer look at integrated invoicing and how it can work for you.
Sites deserve to be paid for completed study activities in a timely manner. Payment milestones such as examination completion, lab result analysis, subject visits are known in advance and documented in the master fee schedule for the study or site. Since these billing milestones are well-defined, the study can be configured to automate the creation and submission of site invoices. This eliminates paperwork for the sites, ensures accuracy, relieves study managers of invoice verification activity and speeds payment.
VISION™’s integrated invoicing functionality allows configuration of invoice line items in a flexible and powerful manner. Examples include:
- Subject enrollment
- Study visit completion
- Physical exam completion
- Lab samples drawn and sent to lab
Invoice line item generation can be tied to field completion, a form’s state (e.g., Reviewed or Finalized), the states of a set of related forms, or a combination of the above. Sites across a study are rarely run the same, and it is not uncommon to see a variation in payment schedules across sites. VISION™ allows the invoiced amount for each line item to be configured for each individual site if desired.
It’s common practice to configure the EDC so that the investigator sign off on each invoice activates submission. This serves as an indication that the investigator has reviewed and approved each invoice. Did you know that VISION™ can also be configured so that the invoice can be annotated when payment has been made? Study monitors and project managers can easily see the real-time status of all invoices using VISION™’s reporting tool.
Streamline trail administration activities by using this powerful feature! Sponsors/CROs who don’t take advantage of integrated invoicing often tell us they wish they had used it.
Learn more about integrated invoicing in this International Animal Health Journal article.
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Prelude Dynamics, LLC, has released some exciting new enhancements to the VISION™ Reports tool. This function of their Electronic Data Capture (EDC) system allows users to view data according to the criteria of their choosing at any point in the study. Reports can be saved, shared with other users, and added to each user’s Dashboard for convenience.
Users can now…
- Easily specify report content using a drag and drop interface.
- Include data from forms in multiple visit days (e.g., Physical Exams across all visits)
- Sort results by any column’s ascending or descending order by clicking on the column header
- Filter fields by typing into a field at the top of each column
- Download any report into Excel with a new and improved interface
The Reports feature of VISION™ has always been a useful data management solution, and is one of many ways to ensure data ingegrity. All clinical staff have the ability to create sets of reports that help them focus in on important data such as clinical end points. The ability to export these reports is a valuable tool for bio-statisticians and project managers alike. Now, clinical trial conduct and management have gotten even easier with Prelude’s addition of a convenient, new user interface.
Prelude constantly strives to assist the health industry in their pursuit to bring innovative pharmaceuticals to consumers. Stay tuned for even more updates from Prelude as we make it easier than ever to conduct a successful clinical trial.
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