• How to Test an IRT: A Primer for Users, Part II

    You’ve worked through the user requirements for your clinical project and how it will be implemented by your Interactive Response Technology (IRT/IWR/IVR) vendor. Your vendor has built the system and completed their verification testing to confirm it meets user specifications (see How to Test an IRT, Part I). Presumably your team has also had a chance to join the vendor for an informal walk-through of the system to confirm, in global terms, that it correctly supports your project. +

  • Practical IRT Design from Veracity Logic

    “Configurable” and “modular” are claims made by many companies providing clinical IRT (IWR/IVR) services today. Configurable means that system changes can be made to meet the specific needs of a clinical trial without requiring days of coding by a vendor’s development and technical support team. Modular means clients only pay for the functionality they need. Veracity Logic’s VLIRT® solution is built on a configurable, modular foundation that is technology agnostic for integration with other eClinical systems. +

  • How to Test an IRT: A Primer for Users, Part I

    Regulatory requirements and plain old common sense make the documented testing and validation of the electronic systems used in clinical trials of critical importance to the success of any clinical study. To put it bluntly, approval authorities around the world will reject clinical data collected by what regulators deem to be substandard means (see, e.g., 21CFRPart11, EU Annex 11, etc) Veracity Logic is an exclusive IRT (IWR/IVR) vendor, so let’s get into the nitty-gritty of what this means for IRT systems. +

  • Play It Again, Sam: Why Use an IRT?

    We sometimes hear spirited discussions at industry conferences between Sponsors who can’t imagine executing their clinical trials without including an IRT (IWR/IVR) system in the technology mix, and Sponsors who remain partial to things like randomization houses, spreadsheets (still!), supplier-direct approaches, and the like. Two misconceptions on the part of IRT-naysayers are immediately obvious to observers of this phenomenon: • The belief that IRTs are always ‘expensive’ – (no, they’re not) • The belief that IRTs are very limited in what they +

  • Checklists can save you — stress!

    Everyone makes mistakes – it’s part of being human. We’re not automatons who simply complete tasks day in and day out. If only life were that simple. It seems there are always small “tweaks” to any process involving information management and processing. The question is, how do we minimize errors and remove stress from our lives? One answer, simple though it seems, is to create checklists -- quick, focused lists of reminders. Most of us already have Standard Operating Procedures (SOPs) +

  • Optimizing Timely IRT Compliance

    A general finding in the clinical trials industry is that entering visit data into an EDC system by clinical site personnel lags, on average, 11 days behind a clinic visit. This issue of belated entry persists in the industry despite the hopes, dreams, wishes, urgings, and incentives offered by Sponsors and CROs for quicker data access. Typically, IRT (IWR/IVR) systems, which provide clinical personnel with critical information like Subject IDs, randomization to treatment groups, and kit numbers for proper drug +

  • 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 +