• Quick Tip from Veracity Logic: Reducing IRT/EDC Reconciliation

    When integrating an IRT (IWR/IVR) system with an EDC platform, avoid collecting CRF data in the IRT. Optimal goals for deploying an IRT are to screen subjects (i.e., assign a Subject ID), to randomize subjects to a treatment group, and to assign drug to subjects during the trial. We recommend our clients follow a ‘must have’ approach for data collected in the IRT and subsequently pushed to the EDC – in most cases, limiting the data transferred to the Subject +

  • Quality Through The Ages

    Imagine it’s 325 B.C.E and you’re at Aristotle’s school, the Lyceum, in Athens. A builder has come to ask Aristotle’s advice. He explains that his workers have not done well with recent jobs and the customers are finding other builders. He has corrected the issues he’s found in the work but this is costing him his profits for the job when work must be redone. He asks, “can you help me?” Aristotle ponders for a moment, then says, “Quality is not +

  • Selecting an IRT

    One of the most popular features ever published on this website is our white paper How to Choose an IRT for your Clinical Trial. The paper includes a comprehensive checklist of important items to consider when vetting IRT (IWR/IVR) systems. From time to time we like to spotlight this paper as our current Hot Topic, focusing attention on key issues central to IRT selection, and on the offerings of core functionality that vendor managers and other decision-makers should be sure +

  • Pharma Quality at Biotech Pricing

    Earlier this year we attended a conference at which one presenter put up a slide titled, “Pharma Quality at Biotech Prices.” We recall thinking what an odd approach to quality this phrase represents. It could be seen to imply that quality is based on the size of a company and on the amounts spent – i.e., that more is more where quality is concerned. But is this true? +

  • The Art of Making Changes Part 2: Focus on Process

    Change is a constant in the world of clinical study planning. In The Art of Making Changes Part 1: Five Keys we talked about the stress change can generate, and about the five essential elements for achieving painless change management for IRT (IWR/IVR) systems. The present article outlines the components of a successful management process for technical change. +

  • The Art of Making Changes Part 1: Five Keys

    Doctors will tell you that change – any sort of change – is hard on humans. As endocrinologist Hans Selye observed, “Stress, in addition to being itself, is also the cause of itself and the result of itself.” Good changes and bad changes alike elicit stress points on psychological scales. Most clinical trial Project Managers will say the same thing applies to managing changes in clinical studies – especially those that impact data systems (e.g., EDC, IRT/IVR/IWR, etc.)! This +

  • In Search of Patient-Centric Vendors

    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 +

  • How to Think About Document Retention

    Perhaps one of the most inconsistently fulfilled industry regulations in the world of clinical trials is the process for document management, including policies for document retention. Companies vary widely in their approach to these important aspects of drug development record-keeping despite the longstanding industry axiom that says “If it isn’t documented, it didn’t happen!” David Goldston, Managing Director of Veracity Logic, an IRT (IWR/IVR) provider that has been successfully deploying IRT systems globally for more than a decade, has a Master’s +

  • Save IRT Time and Money with an ASCA

    It’s not always big things that make a difference in the efficiency of a clinical trial --- sometimes it’s the smallest things. The IRT (IWR/IVR) database is no exception to the rule. The incorrect formatting of a fax or phone number, or an extra space in an email address where automatic notifications are to be sent can wreak havoc with the best laid plans. Likewise, an error in the spelling of a field label, or failing to update the name +

  • Tips for IRT Startup Meetings

    The contracts have been signed, the study teams are in place (at the Sponsor/CRO and vendors), and it’s time to hold the startup meeting for one of the first data collection tools that will be used for your clinical trial – namely, the Interactive Response Technology (IRT/IWR/IVR) system. An IRT is the tool of choice for subject randomization and management, drug assignment and inventory management, and shipping, and as such is often the first point of entry for subject data +

  • IWRS for Clinical Trials — A Few Notes

    Wondering what Interactive Response Technology (IRT/IWR/IVR) is and where it fits in the world of clinical trials? For a brief intro, take a peek at the interview IWRS for Clinical Trials with David Goldston, Veracity Logic’s Managing Director. +

  • It’s 5PM, Do You Know Where Your Documents Are?

    One of the much-lamented aspects of a regulated industry like pharmaceuticals is the amount of documentation required for the successful conduct of a clinical trial for new drug development. The old industry adage ‘if it isn’t documented, it didn’t happen’ was with us at the birth of modern FDA trials and it remains just as true today. The move from a predominantly paper-based environment to an electronic environment didn’t change a thing – the lament just moved from one venue +

  • IRT – Not An Afterthought

    Planning the official EDC or clinical database for an upcoming clinical trial is a unilaterally intense initiative. This is not always the case for other, also-important, applications used during a clinical trial – including collateral systems like Interactive Response Technology (IRT/IWR/IVR). The IRT serves as a remote ‘front end’ for certain key clinical trial activities. Whereas the EDC is the clinical database, the IRT is widely recognized as the tool of choice for randomizing patients and managing drug inventory and +

  • 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: +