Clinical Data Management Tools
Optimizing Clinical Asset Management means addressing all study needs—from the customized database design through execution of the study and reporting of the data.
Veracity™ is customized with the data management tools and functionality that are right for your study. Tools that maximize efficiency while preserving study integrity.
Asset Optimization
Veracity is customized with the tools you need to optimize the time and resources involved with managing a study—from the perspective of all study constituents.
The application is customized to provide you the Asset Optimization tools that are right for your study and that can help preserve one of everyone’s most valuable assets—time.
Online Randomization
In most clinical trials, randomization is one of the most important features that enable valid statistical inference. Traditional randomization techniques can be time-consuming and have additional limitations.
KIKA’s Online Randomization capability is a list-based system allowing online, real-time randomized assignment of study subjects to pre-selected treatment groups. If necessary, an additional user group may be created to enable a third party to perform the randomization.
Online Adjudication
Struggling to schedule time for an adjudication committee meeting may be a thing of the past with KIKA’s Online Adjudication capability.
This restricted-access feature allows third-party experts to independently review and assess patient outcomes or events. Dedicated pages within the subject’s eCRF allow display of event characteristics, entry of the adjudicators’ assessments, and display of the adjudication results. An automated email notification lets adjudicators know they are needed for the review.
The online adjudication pages remain available throughout the duration of the study for storage and ongoing review of results.
When linked with the ability to integrate all manner of data an imaging into the record, this feature becomes a powerful tool for efficient adjudication.
Data Monitoring
Veracity provides data monitors and managers the means to modify and clarify data through tools that make online data monitoring an intuitive, efficient experience.
Checks Overview
Keeping ahead of data errors means finding potential problems early in the process. The Checks Overview tool automatically checks the coherence of data entered on the same page or on several pages.
The tool provides a visual dashboard that can be used not only to track data defined as incorrect but also to track interesting and relevant information.
Veracity’s intuitive interface makes this an easy to use function.
Online Queries
Veracity is designed to facilitate improved communication among all individuals who complete, check, and/or validate data.
Data monitors can send a query to an individual investigator by simply clicking an icon, typing your question, and entering your password to sign the query electronically. A query icon on the CRF next to the appropriate field, as well as next to the subject’s ID number in the Case Overview window, will notify the investigator of the query.
For the investigator, answering the query is just as easy. The sender has the opportunity to answer, add remarks, validate the information, and enclose a request.
Monitoring Page Status
Veracity puts you in control and provides quick access to the data for ongoing monitoring.
The online monitoring module includes a page status assignment tool, which allows study monitors to freeze eCRF pages following initial review of the data, and allows data managers to lock eCRF pages following data verification.
Status names as well as associated user rights, such as insert, update, and display are all customized to your needs. Up to 3 levels of status can be configured within a project to handle potential complex monitoring workflows in your organization, and to provide easy access to the information necessary for optimal data monitoring.
Site Visit Monitoring Report
As part of the online monitoring module, monitoring visit reports (MVR) are implemented within the website as specific eCRF.
These forms allow monitors to record on-site visit activities, and can be customized in order to match the sponsor MVR template. A specific MVR overview list summarizes the status of all MVR pages.
Instant Data Reporting
Information is powerful and access to the information is paramount. Having access ready at hand is not optional. That’s why Veracity offers the tools needed to instantly access exactly the data you need, when you need it.
Veracity offers a range of reports available to provide you fast access to the data you need with just a few clicks.
Study Progress Report
The Study Progress Report facilitates the monitoring of study progress by providing, on an investigator, site or country level, the distribution of each eCRF page by status (including signature and monitoring status).
Event Tracking Report
The Event Tracking Report is designed to count and track the occurrences of any event (as identified by a date in the eCRF) across time (yearly, monthly, or weekly) on an investigator, site or country level.
Follow-Up Visit Management Tool
Tracking a subject’s follow-up visits can be critical to ensuring comprehensive data. The Follow-Up Visit Management Tool facilitates the monitoring and enforcement of follow-up visit completion, as well as the navigation through follow-up forms within the eCRF.
Reports can include distribution of each follow-up visit, sorted by investigator, site, or country.
Real-Time Data Exporting
When you need to take an interim look at the data, Veracity makes it easy. Through a secure password-protected portal, data can be accessed and exported in various normalized formats -- on demand, whenever you want, and in real-time.