AGILE or Not – The Team Makes the Difference

IRT Essentials, Newsletter Archive

We’ve been surprised over the past year or so by the number of IRT companies that have begun touting AGILE methodology as the knight-on-a-white-horse come to save us all from our clinical trial timing dilemmas. Oh, if only it were that simple!
A Decade of Agility

Veracity Logic has been using an AGILE-style methodology for nearly 10 years now. What we have learned is this: In its cleanest form, the approach does allow project teams to implement systems faster than with the traditional waterfall. But — unfortunately for all of us – an AGILE process is not what finally makes a difference in the timelines of a project.

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?

We’ve Got You Covered: Countries

IRT Essentials

Interactive Response Technology solutions must reach people wherever they are throughout the world. Subjects/Patients, Clinical Sites Users, Warehouse Distribution Staff, and the Clinical Project Teams exist in a more and more distributed environment. Veracity Logic’s web presence exists anywhere users are able to reach the Internet. Our Help Desk staff are available to all users via email or phone.

In addition, we have phone lines available in 50+ countries including:

Protecting the Study Blind in IRT Processing

Case Studies, IRT Essentials

In recent years there has been an upsurge in professional vigilance with regard to maintaining the study blind in clinical trials. Concern about incidental unblinding — i.e., an unblinding or ‘partial unblinding’ that occurs accidentally in the course of modifying some other aspect of a trial– has grown in proportion to new strategies and techniques adopted by the industry. These concerns apply to all sectors of a study strategy, including outsourced players like IRT (IWR/IVR) systems. Veracity Logic founder Steve Zimmerman led a panel of colleagues in discussion of this subject at the CBI IRT conference in Philadelphia in 2015.

Right-sizing your IRT Vendor…

IRT Essentials

It’s almost axiomatic that no one was ever fired for choosing one of the top five CROs to run a clinical trial. After all, these companies have the most resources, the best people, more experience, and great systems and processes. They’re able to sell with their A-team.

Unfortunately for many small to medium sized customers, such companies sometimes deliver with their “C Team” saving their A-team for the bigger, more highly funded programs. For smaller companies, a project’s budget may be a tiny fraction of the gross revenue of the larger company. If you contract with a company having $4+ billion in annual revenue, your $3 million budget is only 0.075% of their revenue. Unfair, definitely. But a reality.

Seven “everyday” benefits of using an IRT

IRT Essentials

Major players in clinical trials have acknowledged the important role of early-input data from Interactive Response Technology (IRT/IVR/IWR) for Risk-Based Monitoring (RBM) assessments. (See previous hot topics on the subject by selecting All Hot Topics from the Main Menu.) A few examples of the IRT data available to the Site Monitor or Clinical Research Associate (CRA) for RBM are:

When NOT to use an IRT

IRT Essentials

As a dedicated IRT provider for more than a decade, Veracity Logic has deployed many systems for subject randomization, subject management, and management of study drug for all phases of clinical trials, including numerous Phase 1,1b, and 2 exploratory trials.

But a lingering conundrum in the industry with regard to these smaller studies is this: At what point does it stop making sense, in terms of per patient cost and savings in manual effort, to use an IRT system at all?

We help clients sort out the pros and cons of this question before irreversible commitments are made one way or another. The key factors for Sponsors to consider when deciding whether or not to use an IRT, while obvious in one sense, can get a bit muddy in others. Grids like the one below can help sort things out.

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:

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.