Push vs. Pull — Tips on IRT Data Integrations

Case Studies

The Challenge:

Your EDC system will house the bulk of your clinical data for the upcoming clinical trial but you’re using an IRT for screening, randomization, and drug assignment. What’s the most efficient, cost-effective way to accomplish two key study goals: to integrate certain data as needed (in a timely fashion), and to avoid time-wasting duplication and reconciliation requirements between systems?

Using Enrollment Thresholds

Case Studies

Problem: A classic struggle in the world of clinical trials is how to ensure there is ‘just enough’ drug at each study site throughout the trial – that is, how to achieve minimal wasting of precious investigational product, but minimize, at the same time, the risk that a site will run out of stock and miss enrollment opportunities that cause study delays as a result. How can your IRT (IWRS/IVRS) system help?

Solution: Veracity Logic’s VLIRT® system allows clients to assign individual enrollment thresholds for each site in the study. A site can be defined as a Low, Medium, or High enroller based on best industry information at the onset of the trial. Each enrollment level feeds into the study’s resupply and inventory management algorithms to determine the optimal amounts of drug to be provided to the site – at initial shipment, for baseline maintenance, and in terms of resupply alert levels for study drug. Recognizing that the one firm rule of clinical trials is that change will occur, enrollment thresholds in the VLIRT® system are easily configurable throughout the study – threshold designation can be changed by Project Managers as events dictate at any point in the trial without requiring custom coding or vendor involvement.

The application of enrollment thresholds is particularly useful when the design of the study doesn’t permit the use of predictive resupply functionality. Predictive resupply is not always a good option for low numbers of users and dosing visits, nor for studies where visits are too close together to handle a just-in-time approach to shipping. In such cases, enrollment thresholds can help project managers put study drug where it will do the most good throughout the trial.

Meet VL at CTS Southeast 2017 in Cary, NC

Events, Newsletter Archive

This year’s CTS Southeast focuses on “Developing Best Practices and Incorporating Novel Technologies to Meet the Demand of More Complex, International Clinical Trial Supply Chains”.

Veracity Logic’s VLIRT® platform includes both Interactive Web Response (IWR) and Interactive Voice Response (IVR) components. We provide a clean, table-based, low graphics intensity solution which our customers have found appealing for its wealth of features, ease of use, and speed.

Why do I need an IRT?

IRT Essentials

Long gone are the days when Interactive Response Systems (IRT/IWRS/IVRS) in clinical trials were thought to be just tools for simple 1:1 assignment of subjects to treatment groups, a no-brainer easily replaced by a few lines of code tagged onto an EDC platform. IRTs are now recognized as go-to systems of choice for controlled management of:

Managing Users in the IRT

Case Studies

Managing Users is one of the key functions of an IRT system in a clinical trial. Typically, IRTs provide the important subject randomization and drug supply management activities for the study. Assigning access to the array of permissions that determine what each user can see and not see in each arena must be foolproof, easy to set up, speedy to change and maintain, and friendly when it comes to adding and subtracting Users throughout the life of the study.