In Search of Patient-Centric Vendors

IRT Essentials

The recent Outsourcing Southeast conference in RTP, NC highlighted one of the hot topics currently buzzing in the pharmaceutical industry, i.e., the need to define and implement a more patient-centric model of clinical trials.

The concept of patient-centricity in the drug development world consists of several basic struts:
• Engage subjects/advocacy groups as partners in the process
• Develop protocols, processes, and systems that are maximally user-friendly (i.e., long on feasibility, convenience, and common sense)
• Put patient interests and point of view on equal footing with corporate research objectives

A Powerful Approach to Visit Windows

Case Studies, IRT Essentials

Having robust information on study visit windows and scheduled activities that is easily configurable (and reconfigurable as need be) is an important requirement when vetting IRT (IVR/IWR) systems for clinical trials. What kind of information should you look for?
First, there are the basics: scheduled activities, activity windows, and options for window enforcement. Here’s a project example from our VLIRT® system:

User Experience = Power+Simplicity!

IRT Essentials

The Challenge:

As technology gets more and more sophisticated, data collection systems for clinical trials are at risk of becoming less and less intuitive for users. Accordingly, the importance of the User Experience has moved to the forefront in many recent pharmaceutical conferences. The challenge for the pharma-tech industry is obvious: How to deliver more and more power under the hood while remaining/becoming more and more user friendly for the diverse population of users at clinical sites around the world?

Risk-Based Monitoring with IRT

IRT Essentials

The key to effective Risk-Based Monitoring (RBM) is data – having essential information in your hands in a timely fashion.

Interactive Response Technology (IRT/IVR/IWR), which long ago had its start as a ‘randomization platform’ for clinical trials, is now a powerful tool-of-choice for subject and drug supply management, yielding data that can and should be leveraged as RBM support for clinical studies.

Good RBM enables study CRAs/PMs to monitor, without leaving their desks, the status of key project variables – i.e., variables that indicate potential risks that might require an enhanced response, like scheduling a site visit, focusing additional site training, or feeding back to decision makers issues and potential issues in study conduct.

Getting to Market Faster…

IRT Essentials

Getting to market faster is one of the major goals of every pharmaceutical company. Going paperless is one way CROs are reducing the time–and costs–required to complete and close a clinical trial.

According to CenterWatch (June 27, 2016), Sponsor use of electronic Trial Master File (eTMF) applications has doubled in the past two years. At the same time, use of paper for Trial Master Files has dropped to 28%.

As more CROs adapt to being paperless and bring their eTMF applications online, they need vendors who are able to keep up the same pace. Aware of the goal, Veracity Logic uses an electronic repository to store all of its project documentation. Once documents are fully executed (all relevant parties have signed off), they are moved to a shared electronic portal where the client is given access to download on demand any and all documents required for the Trial Master File.

“We understand the goals of the industry and are supporting those goals by having project documentation available to our clients long before database lock,” says Andrea DeStefano, Project Manager at Veracity Logic.

Accessing Event Notifications

Case Studies

The Challenge:

For a study lasting several years, it’s common to have turnover of study personnel. When this happens, new users need access to the notifications sent by the system prior to their arrival. Typically, new users have to ask for printouts of specific prior notifications, or the Help Desk is asked to send copies of all the past notifications generated for the site. How to streamline the process?

The Solution:

The Veracity Logic development team revised the Messages functionality of the IRT CORE system so that new users are, by default, able to view ALL of the notifications generated since the beginning of the project and appropriate to their assigned user role and site(s). Users can also choose to re-send prior notifications on demand.

Summary Rollup Reports…

Case Studies


Your drug supply depots are using up study drug faster than expected. You need to track down the problem. For one thing, you want to take a quick look at Subject Activities and see how many instances of unscheduled resupply of study drug have occurred in your study thus far, at all clinical sites globally, and, in particular, at Canadian sites, where the biggest problem seems to lie. How do you quickly get the information you need from your IRT?

Veracity Logic’s IRT solves this problem with on-screen Activity Rollup function. A toggle on the Activities page brings up a summary report filterable by Country, Site, or Activity. Activity totals are provided at the Site, Country, and Study level (as defined for your project). The same summary data is presented for all other activities, including scheduled visits and unscheduled activities (such as Screen Failures, Early Withdrawals, and Unblinding).

Subject Rollup functionality, accessible by a toggle click on the Subjects page, is also a part of Veracity Logic’s standard offering. The Subject Rollup report provides at a glance the record of all scheduled subject visits that have occurred (and their dates) within and across subjects. This report is filterable by Subject Status, Site, and Country,

Want to know more about the powerful standard offerings of Veracity Logic’s IRT?

Leverage IRT Capabilities for Project Management

Newsletter Archive

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.