• Strata Versus Cohort: A Clarification

    We’ve seen confusion in recent IRT (IVR/IWR) RFPs and study protocols in the use of ‘strata’ and ‘cohort’ when describing desired approaches to randomization. The words are often used in opposition – that is, one is often specified when it’s really the other that’s required. This confusion in terminology can negatively impact the bidding timeframe, requiring back and forth clarification between vendor and sponsor, or worse yet, can wrongly inflate or deflate the final bid tally. Correcting after the +

  • How to Get a 2 Week IRT Rollout: Re-Inventing the URS

    One of the things we try to do with our weekly hot topics is bring to the forefront the latest excitements, ideas, and controversies surrounding clinical trials and Interactive Response Technology (IRT/IVR/IWR). Among the most hopeful initiatives touted in recent industry conferences is the goal of implementing a 2 week rollout for an IRT system, from Contract Approval to Release for Client Testing (UAT). Smoke and mirrors? Pie in the sky? Or is it actually feasible? +

  • Actionable Intelligence from the IRT for CRAs

    One of the hottest topics in the clinical trials industry today is the transition to Risk Based Monitoring (RBM) (see Guidance for Industry: Oversight of Clinical Investigations_ A Risk-Based Approach to Monitoring; and ICH E6 R2). RBM includes the addition of a new ‘centralized monitoring’ function which focuses on risk within and across sites and even across projects, data that is then bundled to inform CRA activities. But the industry is in transition: the vast majority of clinical trials +

  • In the News: An Overview

    At three recent clinical trial conferences, industry thought-leaders laid out their current prospectus for revolutionary redesigns of traditional clinical trials processes – in many cases (but not all), leveraging technological advances in the interest of new concepts and efficiencies. +

  • What It Means to be Flexible

    Companies providing IRT (IVRS/IWRS) systems that support clinical trials know they must be seen as being “flexible” in their approach to delivering those systems. Most IRT vendors claim a capacity for flexibility. But what does that actually mean…and how should one expect flexibility to impact cost and timelines? +

  • Name That App

    In November 2016 we developed a post called, “Acronym for This, Acronym for That.” In it we talked about the various names used to describe clinical IRT (IVR/IWR) systems over time. Clinical IRTs started life as Interactive Voice Response (IVR) systems. These systems allowed users to enter clinical data over the telephone. Functions were limited by what could be done via a touchtone interface. Typically, this was limited to recording subject activities, receiving shipments, and unbinding subjects. Later, the industry graduated to +

  • Using Smaller, Specialized Companies for Clinical Trials

    One of the recurring themes at a recent Chicago conference of pharmaceutical professionals was the industry's shift from a longstanding outsourcing model of searching for a 'one stop shop' to a new model which favors employing a horizontal spread of uni-task experts to specifically target the diverse needs of a clinical trial. "The success and wisdom of the new approach speaks for itself," says David Goldston, Managing Director of Veracity Logic, an IRT (IWR/IVR) provider. "We obviously agree with Sponsors +

  • Putting Study Control Where It Belongs

    “Patient-centric clinical trials” is a hot topic in the pharmaceutical industry today. To be “patient-centric” is to consider in a new way the needs and realities of the patient experience, and to allow that understanding to inform your clinical trial all the way from study design through final visit. The idea itself is simple — to proceed in a manner that is informed from the outset by what works and doesn’t work best for the patient (as opposed to the makers-of-protocols). +

  • Hey, Do You Guys Do Many Phase 3’s?

    We’ve recently had a few prospective clients ask us to add to our company's introductory materials a couple of additional details about the project structure and client base of our Interactive Response Technology (IRT/IWR/IVR) – specifically, client type and project phase. To that end, we’ve drawn together two key metrics that will let customers know at a glance the total project experience landscape here at Veracity Logic. We thought we’d share these today with you, our website/blog/newsletter readers! Drumroll! Client Base: About 50/50 +

  • A Cautionary Tale: Configurability and Real Life

    “Configurable” is a much bandied term these days when folks in the clinical trials industry get together to talk about technological support systems like IRT (IWR/IVR). A configurable system is taken to mean “a state of being that is the opposite of custom-coded”. In other words, faster, cheaper, easier to adapt; changes that can be made with the click of a button rather than requiring two days of coding. In its most honest form, a system designed with an eye toward +

  • Revisiting Efficiency: How to Integrate your IRT with EDC

    The Issue: One of the most consistent questions we get from prospective clients is how best to handle data integration between the IRT and EDC systems being used for a clinical trial. The EDC system will house the bulk of the clinical data, while the IRT is needed for randomization and drug assignment. What's the most efficient, cost-effective way to accomplish two key study goals: to achieve integrated data in real time, and to avoid time-wasting duplication and reconciliation requirements between +

  • AGILE or Not – The Team Makes the Difference

    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 +

  • User Experience = Power+Simplicity!

    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

    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

    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 +