• 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! +

  • Enrollment Expectations and Site Management

    Problem: Your clinical trial will be conducted at more than 50 clinical sites in the U.S. and another 40 internationally. The incidence of disease for the indication of interest varies widely based on geography, but your IRT algorithm treats sites as a unitary phenomenon--a sure path to cost inefficiencies. How can you leverage known statistical differences to control drug waste, shipping costs, and reduce problems with drug allocation? Solution: As part of its CORE system, Veracity Logic's IRT (IWR/IVR) includes +

  • Veracity Logic-Medrio Integration Spells Success

    Case StudiesFeb 28

    Through Integration of Medrio and Veracity Logic, Atlantic Research Group Expands Capabilities Finding themselves under a strict timeline and in need of drug supply management, Atlantic Research Group was searching for a way to bolster their software repertoire. Using a free API from Medrio, they were able to access the comprehensive drug supply management capabilities of Veracity Logic without forfeiting Medrio’s top-shelf electronic data capture. +

  • 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 +

  • Why Visual Verification?

    Case StudiesFeb 21

    The Problem: On the one hand we’ve got statistics. On the other hand, we’ve got human lives. Because of the latter, our hearts tend to have zero tolerance for errors in clinical trial data. How do we find the right level of risk and quality control (QC)? Let’s tempt the wrath of risk assessors everywhere and look at the issue. What’s the real purpose of QC? To be sure, it is NOT to achieve perfection. On that most of us +

  • Getting to Market Faster…

    Getting to market faster is one of the major goals of every pharmaceutical company. Going paperless is one way CROs are reducing the time--and costs--required to complete and close a clinical trial. According to CenterWatch (June 27, 2016), Sponsor use of electronic Trial Master File (eTMF) applications has doubled in the past two years. At the same time, use of paper for Trial Master Files has dropped to 28%. As more CROs adapt to being paperless and bring their eTMF applications online, +

  • User Power: Managing Cohorts

    The Problem: The management of multiple cohorts is a standard offering of most IRTs. In the common sequential model, when Cohort 1 reaches a pre-designated limit the cohort is closed by the system and subjects can no longer be enrolled into that cohort. Problem: The design of your study is such that the maximum number of subjects in each of your four planned cohorts cannot be fixed at study startup, and more than one cohort can, in certain circumstances, be +

  • Do You Need a Secondary IRT Vendor?

    The Challenge: The unpredictability of clinical trial scheduling and timelines is a 'given' in the world of pharmaceuticals. Seasoned professionals have learned the hard way that one's chosen vendor in any given domain may not be sufficient to handle whatever comes along -- in particular, the tendency of multiple studies, originally scheduled to begin at nicely manageable intervals, to suddenly bunch up in the same month or quarter. In addition, variations in study needs, size, and rules of conduct makes it +

  • Dynamic Randomization — Striking a Balance

    Case StudiesJan 24

    The Problem: Randomization -- that is, the truly random assignment of patients to a treatment group in a clinical trial -- is the gold standard approach to producing statistically valid results in drug studies. Randomization is intended to eliminate bias -- theoretically, the myriad of variable and potential variable differences between patients, both known and unknown, should even out over time in infinitely large samples. But study sample sizes in the real world are not infinite. In many cases, they're not +

  • Predictive Inventory – Optimizing Drug Supply

    Case StudiesJan 17

    The Challenge: One of the greatest challenges in the conduct of a clinical trial is managing the expensive and often limited supply of investigational drug needed for the project. Anything that can help reduce waste and shipping costs while ensuring that clinical sites will have the drug they need when they need it is on the 'most wanted' list for the pharmaceutical industry. Since Interactive Response Technology (IRT) is one of the primary tools for drug assignment during a trial, +

  • Meet Veracity Logic at SCOPE 2017…

    The 8th Annual SCOPE Summit, taking place January 24-26, 2017 in Miami, FL, will offer three stimulating days of in-depth discussions in 13 different conferences, 6 pre-conference workshops and 2 symposia focused on a myriad of issues related to clinical trial planning and management, including domains seminal to the world of Interactive Response Technology (IRT) -- e.g., Data Integration, Site Management, Patient Engagement, Mobile Tech, Project Management, Outsourcing, Forecasting, Quality in Trial Conduct, Risk-Based Monitoring, Post-Marketing Studies, and more! Veracity Logic’s +

  • VL Overview 2017

  • Third-Party Integrations…Reviewing What Matters

    With the cost of executing clinical trials continuing to spiral upward, Sponsor and CROs are increasingly relying on the ability to integrate multiple service providers on a single study. Integration...true integration, that is...must accomplish three key procedural (and thereby cost) savings regardless of the types of applications/tools being integrated: First, the integration must eliminate costly and inefficient redundancies, and the reconciliation activities they inevitably engender. Second, data sharing between systems must occur in close to real-time in order to avoid +

  • Direct-to-Subject Shipping

    The Challenge: In order to help meet global enrollment targets, the Sponsor wanted to reduce the number of clinic visits each subject would need to make while still being able to assign drug every week. The goal was to find a way to deliver drug directly to subjects at home, and on a discretionary basis. Additionally, the Sponsor wanted to allow sites/subjects to be able to choose (and change their minds if need be) at a visit level whether to receive +

  • Enhancing the IRT User Experience…

    The Challenge: During the course of a clinical trial, users are required to learn and use a variety of systems. To ease the burden, IRT vendors need to provide an attractive, easy-to-learn, easy-to-use IRT interface that provides users with much-desired 'data at a glance' capabilities and allows them to execute critical tasks quickly, with a few simple clicks. The Solution: To meet this challenge, Veracity Logic has developed a table-based, data-centric approach that greatly simplifies the user experience by incorporating basic data processing/error +

  • Industry News: Managing Complexity

  • Using Veracity Logic IRT’s Help Page…

    Help, how do I get new documentation to the users?! Problem: Mid-study issues make it clear to your Project Manager that sites need new instructions to improve and clarify certain aspects of study conduct. The Project Manager puts together a User Guide, in six languages, for all study sites. The question now is how best to provide it to the clinical sites to insure it will be readily available for easy use. Solution: Veracity Logic’s IRT solves this problem by allowing authorized +

  • Accessing Event Notifications

    Case StudiesNov 29

    The Challenge: For a study lasting several years, it’s common to have turnover of study personnel. When this happens, new users need access to the notifications sent by the system prior to their arrival. Typically, new users have to ask for printouts of specific prior notifications, or the Help Desk is asked to send copies of all the past notifications generated for the site. How to streamline the process? The Solution: The Veracity Logic development team revised the Messages functionality of +

  • Requesting Shipments …

    Case StudiesNov 22

    Shipments, manual or automated, have it your way… Problem: So it’s time to decide what types of shipment requests you’ll use in your clinical trial. There will be crunch times when Manual Requests are essential; other times when system-generated Automatic Requests are optimal (i.e., generating a shipment when a site’s inventory reaches a pre-set level). For some studies, a Predictive approach (modifying resupply based on multiple variables) is desirable to prevent drug wastage and to keep busy sites from running out. And +

  • Acronym for This, Acronym for That

    Question: What is RTSM? The recent CBI IRT Conference in Philadelphia made clear that a new acronym -- "RTSM"-- is coming into popular use to describe IRT systems. What is RTSM? And do we really need another acronym? Response: Our industry started using the term "Interactive Voice Response Systems (IVRS)" in the early 90's to describe the typical phone-based systems used to capture IRT data for clinical trials. As use of web systems expanded, the term "Interactive Web Response Systems (IWRS)" sprung into +

  • Handling Data Corrections…

    Case StudiesNov 15

    Problem: There are many options for processing manual data changes in an IRT system. Some vendors make all data changes for the clinical site users. Others have electronic systems where users can request and approve changes, while still others require 'wet' signatures. What's the best option for achieving the two key goals of change control, i.e., documenting user approval while streamlining the process so it doesn't take days to make a change? Solution: At Veracity Logic, we put our emphasis on enabling and +

  • Tracking Temperature Deviations…

    Yikes, someone left the package out in the heat! Problem: Your drug must remain within a set temperature range at all times. How are you going to ensure drug that experiences a temperature deviation is not distributed to subjects? Your packaging and transport vendor(s) will record temperature deviations that occur between the manufacturer and the clinical site. Great! But what about the IRT’s inventory tracking? How does it know to hold that drug? And what to do with it next? Solution: When the site receives +

  • Drug Hiatus…

    Hey, I need a break from the dosing regimen…! Problem: Your study has a fairly complex drug titration pattern. In addition to multiple pre-planned titrations, subjects in your clinical trial can go up or down one dose level in the maintenance phase, based on medical assessment. If the subject has an unusual medical event intervene in the 'dose escalation' phase – for example, a hospital stay for an unrelated issue – the subject may either need to be discontinued from the trial +

  • Protocol Deviations: We need authorization…quick!

    Case StudiesOct 25

    Problem: The study has been suffering from slow enrollment. An excellent candidate, medically speaking, walks into Site 101 but there’s one problem: The minimum enrollment age for the clinical trial is 18. The age of the new potential candidate is 17 years, eight months. The Study Coordinator at the site not only needs a quick decision, but one that protects the integrity of the protocol at the same time. What to do? Solution: Veracity Logic’s IRT system provides Authorization Codes for just +