Use the VLIRT® to manage subject demographics, stratifying information, visit status, next activity, and more, in a user-friendly table format that provides an at-a-glance overview of all the subjects in the trial. No need to query or scroll through the system to get summary data on subjects! The VLIRT® subject management module is readily configurable to meet protocol needs and international regulatory requirements.

  • 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 +

  • 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 +

  • 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 +

  • VL Randomization Options

    VL Randomization Options +

  • Case StudiesMay 23

    Replacing Study Subjects

    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 +

  • 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 +

  • Case StudiesOct 25

    Protocol Deviations: We need authorization…quick!

    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 +

  • Case StudiesSep 25

    Handling Subject Privacy Issues…

    Oh my, not all demographics are created equal… Problem: Your clinical trial has hundreds of subjects taking place in 32 countries. One of the best ways to help sites ensure accurate identification across subject visits is to require not only a unique ID for each subject but also a linked Date +

  • Subject Management and Demographics

    Handling a World of Diversity Your clinical trial is global and age- of-subject is a critical variable. For most countries, Date of Birth is collected. But some countries, like Germany, regard the collection of Date of Birth as a violation of subject privacy. Not only that, your present IRT system requires that +