Real-time Integration between IWR (web) and IVR (phone)…

Case Studies

Problem:

Your global trial includes 32 clinical sites in 12 countries and all but two have reliable access to the internet and your web-based IRT system. In the other two locations, internet connectivity comes and goes like a bad dream … with entirely too much down time for the sponsor’s comfort. An IVR (phone) option is added to the IRT, meaning that users at a site, at any given time may be using either the IWR (web) or IVR (phone) platform or both … sometimes attempting to modify the same subject record. How will order be kept?
Solution:

Veracity Logic’s IRT is designed to provide instant integration between its web and phone systems when circumstances call for IVR (phone) capability. If two persons attempt to modify the same data at the same time, only the first to save their change is allowed to proceed. The other is sent an instant on-screen message (or voice message) that the data has already been modified by another user, and the new data becomes available on the phone (if entered on the web) and on the web (if entered on the phone) as soon as the user returns to the menu. The IRT’s audit trail captures the data updates made via IWR (web) or IVR (phone).

Want more details about IVR interfaces? Choose Contact Us from the menu above.

Customizing Subject Unblinding …

Case Studies

Problem:

Protocol complexities often call for a customized approach to unblinding subjects in your clinical trial. First, authorized users need to receive an on-screen message with a very specific set of instructions when they begin to unblind a subject. Second, they need to be presented with a Yes/No option to confirm that the Site Monitor or Sponsor has been alerted. Third, the user needs to request and receive an immediate authorization code from a 24-hour Medical Monitor. That code must be entered before the unblinding can be completed. And of all of this must be accomplished quickly and efficiently.

Your current IRT’s standard system allows none of these options, and the study startup clock is ticking! What to do?
Solution:

Veracity Logic’s IRT platform is designed to maximize configurability and minimize complex coding requirements for a variety of custom setups such as the ones described above. These custom unblinding modifications can be accomplished with no additional impact on project development timelines and no loss of efficiency, saving precious time, when an emergency unblind needs to occur during the study. Authorization codes are held within the IRT system; available codes are easily accessed by the designated decision makers. A code documenting permission to register the subject is provided to the Site for entry into the IRT database. The fact that an unblinding has occurred can be easily tracked by Biostatisticians. In addition, for each study, clients can specify the list of users who will receive notification of each unblinding occurrence. The content of that notification is also readily configurable for study needs.

How to Choose an IRT for Your Clinical Trial (Obsolete–See 10/17/2017)

White Papers

Interactive Response Technology (IRT) is the currently accepted term for IVR (Interactive Voice Response) and IWR (Interactive Web Response) systems used in clinical trials. In the not very distant past, the IVRS was the standard method of adding IRT to the suite of tools used to execute a clinical trial. Development of response technology on the web, which began in the early 2000’s, constituted a paradigm shift for the industry, and fueled the expansion of IRT’s role and capabilities.

Today, the web, not the phone, is the preferred IRT platform for most clinical trials, with some important exceptions—for example when only subject diaries are being collected in the IRT and subjects are asked to call in their self reports. The phone component is otherwise typically contracted as an “also” or “backup” option to the primary web system—most useful in locations where web capabilities remain suspect or when having both IRT platforms available is more conducive to protocol execution—for example, when screening or randomization has to occur in a surgical arena with the subject on the table! In the modern sphere, integration between the web and phone arms of an IRT platform therefore remains critical, one of the important items on a complete checklist for how to choose an IRT for your clinical trial.

While the technology has surged ahead, information on what today’s IRT systems can do and should offer has lagged behind. And the world keeps changing. Even now, the uses of IRT are in transition—a subject we will return to later.

This article was prompted by requests from our colleagues —Sponsors, CROs, and Clinical Suppliers—for a comprehensive summary of features and issues to consider when vetting IRT systems. Veracity Logic (VL), based in North Carolina’s Research Triangle, specializes exclusively in providing interactive response technology for clinical trials.

The checklist below derives from our experience with more than 125 trials and 50-plus clients, in more than 45 countries over the past decade, including the critical transition years from phone to web. It is a fair statement of capabilities you can reasonably expect from an IRT vendor, and it is our recommended reference guide for issues to consider when selecting your IRT provider.

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Around the Corner

As noted earlier, new uses of the IRT are becoming available almost as quickly as one can define them. As of this writing, some cutting-edge capabilities, not yet provided by all or even most vendors, include:

Forecasting: A step beyond predictive inventory control during a trial, providing additional planning algorithms for drug manufacture and distribution.
Mobile compatibility: The ability to access the IRT system on diverse mobile devices and platforms, with no diminishment of look, feel, or capability.
Drug pooling capabilities: The ability to assign drug across protocols, generally controlled by a dashboard-type management tool within the IRT.

Companies vetting IRT vendors should be sure to initiate conversations on the status of these capabilities and/or plans for implementation in the future.

Checklists like this are living documents; they must be updated as the industry progresses. Got more items to add to the checklist? Send them to info@veracitylogic.com.

Subject Management and Demographics

Newsletter Archive

Handling a World of Diversity

Your clinical trial is global and age- of-subject is a critical variable. For most countries, Date of Birth is collected. But some countries, like Germany, regard the collection of

Date of Birth as a violation of subject privacy. Not only that, your present IRT system requires that three-part initials be entered as a way of confirming subject identity. But some countries regard that as a violation of privacy, too. What to do?
Solution: Demographic Flexibility

Veracity Logic’s IRT system was built to allow demographic flexibility, for these and other subject variables, on a configuration basis within and across studies. In other words, within the same study, Site A can collect Date of Birth while Site B collects only Year of Birth and Age. And it does it as part of the standard system – no time delay for custom coding. Likewise with subject initials – sites easily have the option of entering three initials, two initials, or just hyphens if such identifying information is prohibited. The same configuration option applies to other demographic variables, like height and weight, kg and pounds, BMI, and so on.

This is just one of the many ways Veracity Logic’s IRT meets real-life scenarios with real-life solutions.

Product Recall

Case Studies

Houston, we have a problem…

These are the words no one wants to hear! Your clinical supplies vendor has called to tell you there is a problem with one of your drug batches. You need to locate and recall all kits in the batch for destruction.

– Where are the kits with the bad drug?
– Are there any already shipped to clinical sites?
– Any, heaven forbid, assigned to subjects?