• 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? +

  • 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 +

  • 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. +

  • 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 +

  • 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. +