• 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. +

  • 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 +

  • 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: +

  • 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 +

  • 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 +

  • 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. +

  • 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? +

  • 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. +

  • 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. +

  • 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? +