Subject-Management

Subject Management

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.

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 of subjects in a timely […]

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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 […]

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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 not only needs a quick […]

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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 of Birth (DOB) and […]

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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 three-part initials […]

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