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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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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