VLIRT® combines a fully validated CORE with robust testing of individual project systems to ensure high quality production every time. Our standard System Life Cycle for each project includes development of approved specifications, live-action walkthroughs pre-validation, independent testing and case development, formal Validation Plans, and a formal Validation Summary Report for client review of testing cycles and outcomes. Ask us about User Acceptance Testing, too!

  • How to Test an IRT: A Primer for Users, Part II

    You’ve worked through the user requirements for your clinical project and how it will be implemented by your Interactive Response Technology (IRT/IWR/IVR) vendor. Your vendor has built the system and completed their verification testing to confirm it meets user specifications (see How to Test an IRT, Part I). Presumably +

  • How to Test an IRT: A Primer for Users, Part I

    Regulatory requirements and plain old common sense make the documented testing and validation of the electronic systems used in clinical trials of critical importance to the success of any clinical study. To put it bluntly, approval authorities around the world will reject clinical data collected by what regulators deem to +

  • Quality Through The Ages

    Imagine it’s 325 B.C.E and you’re at Aristotle’s school, the Lyceum, in Athens. A builder has come to ask Aristotle’s advice. He explains that his workers have not done well with recent jobs and the customers are finding other builders. He has corrected the issues he’s found in the work +

  • Case StudiesMar 21

    When the Project Specification and the Project System don’t match…

    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 +

  • Case StudiesSep 12

    Need to shorten startup time without sacrificing project quality?

    Problem: Your study has a hard startup timeline but there have been an array of delays and modifications on the science side of things. You not only need to make up time, you need to make some changes to the specifications for your vendors, including your IRT system which is already +