• Managing Drug Returns with IRT

    Drug accountability and the problems associated with it remain key issues for clinical trial management as we move into 2018. Using an IRT (IVR/IWR) system to manage the distribution and assignment of investigational product (IP) is now a well established practice. Most IRTs these days also include some method of managing and documenting the return and destruction of IP consistent with federal guidelines which require Sponsors to account for all of their trial’s unused drug. But IRTs differ in the +

  • A Powerful Approach to Visit Windows

    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: +

  • Temperature Deviation and IRT

    The ability to track the temperature excursions of an investigational product has taken on an increasing importance in clinical trials. Temp tales and similar devices are used to record the drug’s environmental exposure from the time it is sealed into a shipping container at the warehouse to the time it is unpacked at a clinical site. The electronically recorded temperature history is available for review by project teams and site personnel on demand. A robust IRT (IVR/IWR) must be able +

  • Intuitive Subject Management

    The surest way for a clinical trial data collection system to be rewarded by users with accolades like ‘intuitive and user friendly’ is for the system to be flexible-by-design -- that is, to enable users to modify, by design, standard data views to include project-specific data points whenever the user logs in. This juggling act – standard-yet-flexible – is one of the first criterion one should apply when assessing a new system, whether it’s an EDC, CTMS, ePRO or +

  • Trends, Charts and Maps

    Do you know: • How many registered US-only clinical trials are active as of Jan 1, 2018? +

  • RBM in 2018

    As the new year of 2018 begins, it does so with the transition to Risk-Based Monitoring (RBM) one of the key initiatives on the table for the clinical trials industry. Backed by federal regulators, RBM urges a move away from ‘rote’ approaches to quality control – for example, 100% Source Data Verification -- in favor of a variety of heads-up, algorithm-driven assessments of potential trouble spots, with preventive and corrective actions the key focus for study monitoring activities. Veracity Logic +

  • Managing Drug With IRT

    When selecting an IRT (IVR/IWR) system for your clinical trial, what features should it have to ensure you can adequately manage the critical but logistically complicated world of study drug? Here’s a quick checklist of things to consider: Ability to have ‘at-a-glance’ access to information relevant to study drug– for example, in a straightforward table view – without the need for complicated querying, and with the ability to deliver or withhold types of information based on user roles. An at-a-glance view should +

  • Reconciliation-Free IRT

    One of the questions most frequently asked by clients during demos of the Veracity Logic IRT (IVR/IWR) system is how best to handle the problem of having to reconcile data between a study’s IRT and EDC platforms. The answer is twofold, but simple: First, move data between the two systems in only one direction. Second, set up your study so you don’t duplicate data in the two systems. Electronic integration between the IRT and the EDC systems should be a one-way +

  • Four Ways to Reduce IRT Help Desk Calls

    It’s essential to have a strong 24/7 Help Desk backing up your IRT vendor. But be sure the IRT system you’re choosing also has a sufficient array of ‘do it yourself’ options that will empower your study team to safely do system updates and save time and money by acting independently of the Help Desk. Here are just four ways to reduce the need for vendor intervention: 1. Look for a system with a login screen that enables users who’ve +

  • 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 +