Veracity Logic 2016 Fall Event Calendar

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For the sixth consecutive year, OmniComm Systems, a leading provider of electronic data capture technology, brings together industry thought leaders and life science organizations to explore and discuss how innovations in electronic data capture. Veracity Logic’s full-service Interactive Response Technology (IRT) integrates with OmniComm’s EDC system and many other mainstream EDC providers. Be sure to stop by our booth in …

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

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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

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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.

Can Your IRT System Help You Manage Protocol Deviations?

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Challenge
Your study has been suffering from slow enrollment. An excellent candidate, medically speaking, walks into Site 101 but there’s one problem: The minimum enrollment age for the clinical trial is 18. The age of the new potential candidate is 17 years, eight months. The Study Coordinator at the Site not only needs a quick decision, but one that protects the integrity of the protocol at the same time. What to do?

Solution: Authorization Codes
Veracity Logic’s IRT system provides Authorization Codes for just such occasions. Site users contact designated personnel to obtain a quick field decision as to whether the protocol deviation is advisable for 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. And all of this can be done within minutes! The fact that a protocol deviation has occurred, and the vital specifics of that deviation, can be easily tracked by Biostatisticians using Veracity Logic’s IRT.

Authorization codes can also be used to document authorized unblinding of subject treatment data—wherever there is an intersection between the need for a speedy decision and the need for protection of protocol integrity.

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

Can Your IRT System React to Surprise Protocol Changes?

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If you’re on a dark ocean and spot an iceberg ahead, do you really want to be on board the Titanic? Clinical trials have hidden challenges that surprise sponsors and vendors alike. So using a vendor that reacts quickly is critical to saving time and costs for sponsors.

Large companies are typically unable to quickly steer their ships …

They may seem like a ‘safe choice’ because they’re large but their size can work against them rendering them less nimble to deal with sudden change. Your upcoming trial is critical to moving your company forward. Will your IRT vendor’s inability to react quickly put the trial at risk?

Leverage IRT Capabilities for Site Monitoring

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Wide Range of Applications

VL’s IRT system delivers a wide range of applications for planning site monitoring visits during the life of a clinical trial. Our Subject Management module and Rollup Reports offer a variety of metrics on subject activities, drug dispensation, and other performance variables within and across subjects and Sites. Also, IRT data is typically available before it is entered into the clinical database …this gives Site Monitors an important heads up as they plan their next site visit! Serving sponsors, drug suppliers, and clinical sites, IRTs remain your best information source on the status of your trial.

Leverage IRT Capabilities for Project Management

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Getting Ahead
Interactive Response Technology (IRT) delivers a wide range of functionality for managing your clinical trial — e.g., subject management, visit management, and drug assignment and accountability, and inventory and shipping management. For Project Managers, the Early Reporting aspect of IRTs enables you to get ahead—and stay ahead — of potential study issues. Getting a jump on problems is what effective project management is all about!

Early Reporting
Using an IRT for your study requires sites to access the study system (either by web or phone) in order to enroll and randomize their patients, to record visits and to obtain drug assignment for scheduled and unscheduled visits, and to receive drug shipments at their site. This means data is available in near real time for project management use.

Leverage IRT Capabilities for Clinical Supply

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IRT systems deliver a wide range of applications for managing patient interactions and drug supplies throughout the clinical trial lifecycle. Serving sponsors, drug suppliers, and clinical sites, IRTs remain your best bet for subject randomization, drug assignment and product inventory management.
Seamless Interface Makes For a Satisfied Client

Veracity Logic works closely with Clinical Supply Teams to ensure a seamless interface with project packaging and delivery strategies. We’ve integrated with supply teams from companies like PCI, Almac, Thermo Fisher and more … and we easily do the same with any new supplier. Use IRT to simplify the following processes: Inventory Control, JIT Shipping, Return and Destroy Options, Warehouse and Depot Relationships and Temperature Deviation Tracking which are all included in Veracity Logic’s performance capabilities for your project.

Truth in Science, Truth In Relationships

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You see it everyday … “World Leader, Best in Class, Global This or Global That” … if you remember our article, “Not All Software Is Created Equal,” then I’m sure you’ll agree that all corporate teams aren’t created equal either!

Veracity Logic’s stellar, user-friendly, easily configurable Interactive Response Technology (IRT) system is getting raves from users for its ease-of-use and flexibility because the people behind it know what matters in the world of clinical trials … and in life!