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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CVM’s Office of New Animal Drug Evaluation (ONADE) has launched an initiative that will greatly increase the efficiency of the study submission process. They will now allow submissions through read-only access to online databases in lieu of the submission of copies of the data. Prelude Dynamics is participating in this pilot program with two study sponsors, and we are optimistic for successful outcomes in both. The primary advantages of allowing CVM direct study access as opposed to the submission of copies of the data are:
- For CVM: With access to the online database they will be able to view the data in a more natural, intuitive way. Spreadsheets do not provide the context that the full database can and are therefore not as suitable. With access to the database, CVM can view all the audit trail information right alongside the source data.
- For Sponsors/CROs: Online access eliminates problems with multiple file uploads and file size restrictions that make the current submission process cumbersome. The burden of “packaging up” study data in a eSubmitter-ready format is removed. Submissions will be faster and less costly.
Preliminary results with one EDC system are promising. Both CVM and pharmaceutical companies are enthusiastic for the future of the study submission process.
For studies to participate in the program, some documentation is required up front. Prelude Dynamics has also removed this burden from Sponsors and CROs by offering prepared templates for interested parties. If you are interested, ask your Prelude project manager for a template today! They can help you submit your information to the right people at CVM.
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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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