• 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 +

  • The Classic Conundrum: “How long will it take to make a system change?”

    Case StudiesJul 10

    A never-ending tension in clinical trials exists between a client’s need for quick changes to a technical system – for example, an IRT (IWR/IVR) system in production -- and the vendor’s need for time.  The axiomatic truth is this: the details of clinical trials are often fluid, with the need for changes commonplace. But Sponsors and CROs often get frustrated when vendors say ‘We can’t provide those modifications overnight!” And vendors get frustrated when Sponsors and CROs insist “Why the +

  • 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 +

  • Revolution or Evolution?

    White PapersJun 18

    New technological developments portend radical changes in the way the pharmaceutical industry will conduct clinical trials for new drug development in future – in fact, the rapid pace of techno-change predicts revolution in the wide arena of human health care. But is it really a ‘revolution’ that looms on the horizon? Or is ‘evolution’ the better – and more welcome – description of the road that lies ahead? +

  • Veracity Logic Announces 10% Discount for NCBIO members — Howdy Neighbors!

    EventsJun 5

    In honor of the robust Pharma/Biotech industry here in our home state of North Carolina, Veracity Logic – a provider of IRT (IWR/IVR) services for clinical trials -- has initiated its ‘Howdy Neighbor!’ program aimed at helping NC players get to know the companies and colleagues in their own backyard. As part of that program, we’re now offering a 10% discount on startup costs for IRT services for members of the North Carolina Biosciences Organization (NCBIO). The discount is applicable to +

  • 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? +

  • NC Pharma/Biotech Spotlight: Paidion Research

    With the continued growth of the Pharma/Biotech sector in North Carolina, it’s getting harder to keep up with colleagues and companies. This Spotlight series is part of Veracity Logic’s ‘Howdy Neighbor!’ initiative –a program designed to help all of us who work in North Carolina’s clinical trial industry to get to know the folks in our own backyard! Once upon a time, in the world of new drug development, the pharmaceutical industry made very little distinction between the conclusions +

  • North Carolina Authors: Remember Who You Are

    EventsMay 1

    In the 1980’s, I had the career-changing experience of taking a job in Chapel Hill, N.C., at a small company called Quintiles, a “CRO” -- whatever that meant! -- that was about to change the face of pharmaceutical research. +

  • 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 +

  • Life Science Economic Development Summit

    EventsMar 22

    Open your calendars and make a note to attend the Life Sciences Economic Development Summit on Monday, April 30, 2018, 8 a.m.-4 p.m. at the Raleigh Marriott City Center. +

  • 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. +

  • Come Join Us: Outsourcing Clinical Trials Southeast!

    EventsMar 6

    Outsourcing in Clinical Trials Southeast March 13-14, 2018 Sheraton Imperial, Research Triangle Park, North Carolina +

  • 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: +

  • 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 +

  • Presentation: Actionable Data from the IRT

    The following presentation was recently given to the Triangle Chapter of the Association for Clinical Research Professional (ACRP). Enjoy! +

  • 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. +

  • VL Randomization Options

    VL Randomization Options +

  • 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 +

  • How to Choose an IRT for Your Clinical Trial (Revised)

    White PapersOct 17

    Interactive Response Technology (IRT) is the currently accepted term for clinical IVR (Interactive Voice Response) and IWR (Interactive Web Response) systems used in clinical trials. Today’s IRT platforms provide complex subject/activity management functionality and robust management of drug supply and shipping throughout the trial. While IRT technology has gotten increasingly powerful, detailed knowledge of all the functions an IRT can and should do has lagged somewhat behind. This white paper — which includes an up-to-date checklist for use in the IRT +

  • 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 +

  • Just Say No to One-Kit Shipments

    The Challenge: Striking a balance between effective study drug inventory control and efficient management of shipping costs is not always easy when faced with the real-life complexities of clinical trials. Automated predictive resupply algorithms that help reduce drug waste at clinical sites are now the order of the day for most IRT (IWR/IVR) systems, albeit with varying degrees of effectiveness when it comes to optimizing shipment efficiencies. Even ‘static’ algorithms – e.g., setting a baseline resupply requirement in the system and +

  • Putting Drug Where It’s Needed Most

    Case StudiesAug 29

    The Challenge: Industry statistics indicate that 50% of the sites initiated for a clinical trial enroll 0-1 subjects; with 25% enrolling none at all. With numbers like these, decisions on where and how to distribute precious and expensive study drug become a serious matter for senior management and project teams. +

  • 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: +

  • Sites Are Not Created Equal

    Case StudiesJul 25

    Problem: Why try to push a square peg into a round hole? It's an old saw, but a true one: investigator Sites in clinical trials are widely different in their procedures, their facilities, their local challenges, their staff, their suppliers, their idiosyncrasies. How then does a Project Manager (PM) standardize important aspects of the trial -- things like shipping and resupply processes, predictive algorithms, drug sourcing, and more? +

  • Managing Supplemental Supplies with your IRT

    Required Non-Investigational Materials It doesn’t seem like a big deal until you have to do it – managing the bandages, syringes, saline solution, tubing, and so on, that Sites may require during the conduct of your clinical trial. The non-investigational materials required for use at clinic visits are often regarded as ‘no-brainers’, not demanding much forethought or attention. But it takes only one or two experiences in a complex trial for Clinical Project Managers (PMs) to concede that developing and managing +

  • VL Screen Shots 2017

  • 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 +

  • Selecting a Fast, Adaptable IRT is one Key to Success

    Can Your IRT System React to Surprise Protocol Changes? If you’re on a dark ocean and spot an iceberg ahead, do you really want to be on board the Titanic? Clinical trials have hidden challenges that surprise sponsors and vendors alike. So using a vendor that reacts quickly is critical to saving time and costs for sponsors. +

  • Five IRT Assists for Clinical Project Managers

    Case StudiesJun 27

    Challenge: You're a Clinical Project Manager (CPM) given a study halfway through enrollment and you need to get up to speed on study status FAST! How can your IRT help? Solution: Fortunately, you're using Veracity Logic's Interactive Response Technology system, VLIRT®. Here are five key features geared toward CPMs who find themselves in just this predicament. +

  • Ten Areas to Find ROI From Your IRT System …

    Conducting a clinical trial – even a small one – is expensive. Pressure to contain costs is a constant presence in the lives of procurement managers, project managers, and senior personnel in all operational areas of Sponsor-companies and CROs. Accordingly, vendors who serve the pharmaceutical industry also live under intense pricing pressure. A demonstrable ROI – Return on Investment – is therefore a minimum requirement when considering whether a particular service provider is a worthy addition to the project mix. +

  • Right-sizing your IRT Vendor…

    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 +

  • Seven “everyday” benefits of using an IRT

    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

    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 +

  • Replacing Study Subjects

    Case StudiesMay 23

    Problem: Figures presented at a recent North Carolina pharmaceutical conference show that 50% of the clinical sites selected to conduct a clinical trial will enroll zero or only one subject. Even with the advent of social media initiatives and other creative new ways to boost recruitment, enrolling an adequate number of subjects in a timely fashion remains a critical issue for the drug development industry. Eligible subjects, in a word, are precious. Precious, too, are randomization schedules and statistical design. +

  • Tracking Protocol Deviations with Auth Codes

  • Use of Quarantine Strategies to Leverage Investigational Product

    Challenge: The cost of producing an adequate store of investigational drug for a clinical trial remains high – significant enough that new ways to forecast manufacturing quantities, predict optimal shipping schedules, and differentially assign drug to sites based on enrollment estimates are constantly being developed. How might IRT systems provide additional methods of minimizing drug waste during a study? +

  • Getting Data Sooner with IRT Part 2

    The Challenge: In a recent post (see hot topic "Getting Data Sooner") we talked about how using a 'give some, get some' strategy in an IRT system contributes to getting your clinical trial data faster. Users are motivated to enter data in a timely fashion because use of the IRT is required for the site to get critical information required for study conduct and subject treatment -- for example, their next kit number, or a dosing calculation. Visit data +

  • Getting Data Sooner With IRT

    The Challenge: A classic problem in the conduct of a clinical trial is how to motivate site personnel to enter their clinical data in a timely fashion. What can be done to enable project personnel to receive study data sooner? +

  • Push vs. Pull — Tips on IRT Data Integrations

    Case StudiesApr 25

    The Challenge: Your EDC system will house the bulk of your clinical data for the upcoming clinical trial but you're using an IRT for screening, randomization, and drug assignment. What's the most efficient, cost-effective way to accomplish two key study goals: to integrate certain data as needed (in a timely fashion), and to avoid time-wasting duplication and reconciliation requirements between systems? +

  • Using Enrollment Thresholds

    Case StudiesApr 18

    Problem: A classic struggle in the world of clinical trials is how to ensure there is ‘just enough’ drug at each study site throughout the trial – that is, how to achieve minimal wasting of precious investigational product, but minimize, at the same time, the risk that a site will run out of stock and miss enrollment opportunities that cause study delays as a result. How can your IRT (IWRS/IVRS) system help? Solution: Veracity Logic’s VLIRT® system allows clients +

  • Meet VL at CTS Southeast 2017 in Cary, NC

    This year's CTS Southeast focuses on "Developing Best Practices and Incorporating Novel Technologies to Meet the Demand of More Complex, International Clinical Trial Supply Chains". Veracity Logic's VLIRT® platform includes both Interactive Web Response (IWR) and Interactive Voice Response (IVR) components. We provide a clean, table-based, low graphics intensity solution which our customers have found appealing for its wealth of features, ease of use, and speed. +

  • Why do I need an IRT?

    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: +

  • Managing Users in the IRT

    Managing Users is one of the key functions of an IRT system in a clinical trial. Typically, IRTs provide the important subject randomization and drug supply management activities for the study. Assigning access to the array of permissions that determine what each user can see and not see in each arena must be foolproof, easy to set up, speedy to change and maintain, and friendly when it comes to adding and subtracting Users throughout the life of the study. +

  • Risk-Based Monitoring with IRT

    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 +

  • When the Project Specification and the Project System don’t match…

    Case StudiesMar 21

    Sometimes it’s a simple thing that gives quality management theory a challenge. For example: Conventional practice for testing a clinical trial project system asserts the following: When tracing from a test result to the official Project Specification (PS), any discrepancy between the PS and the system requires failing the test step and then re-testing it again in a new test cycle after a correction interval. If we translate this assertion into other terms, the problem with this reasoning becomes obvious: The +

  • VL Summary (“Rollup”) Reports

  • Meet VL at OCT Southeast 2017 in Cary, NC

    This locally-focused event attended by the RTP biopharmaceutical market (and more!) looks at key challenges faced by small to mid-sized biotech and pharma companies in the Southeast and facilitates learning and problem-solving through case studies and discussion among peers. We’d love to meet up! +