CTM

CTM Management

The VLIRT® system provides robust management of all Clinical Trial Materials (CTM), including study drugs, vehicles, and ancillary supplies. Use an IRT to manage:

  • CTM assignments to sites and subjects
  • Subject dosing, including scheduled and unscheduled titrations
  • Batches and Label Regions
  • Individual CTM status – e.g., expiring, damaged, missing, temperature deviation, mis-administered
  • Drug hiatus or skipped dose
  • Drug accountability at the unit (e.g., kit) or sub-unit (e.g., capsule) level
  • Return shipments and drug destruction
  • Interactions with packagers/distributors
  • Sample retention
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Using Enrollment Thresholds

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 […]

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Tracking Temperature Deviations…

Yikes, someone left the package out in the heat! Your drug must remain within a set temperature range at all times. How are you going to ensure that drug which experiences a temperature deviation is not distributed to subjects?

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Reporting Problems with Kits…

Help, the delivery van ran over the study drug …! Problem: Despite the best laid plans, whatever can happen, does happen when a clinical trial is in the field. Examples: Kit 690, the study drug unit about to be assigned to Subject A, was damaged in transit and can’t be assigned. Subject B’s wife, trying […]

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Returned Kits: I need to count capsules but my IRT doesn’t allow it…

Problem: Your study’s protocol calls for the return of unused study drug to the clinical site at each visit, when new drug is distributed.  This drug accountability needs to be documented not merely at the container level, which is the only way your current IRT allows, but at the capsule level as well. You need a […]

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Product Recall

Houston, we have a problem…   These are the words no one wants to hear! Your clinical supplies vendor has called to tell you there is a problem with one of your drug batches. You need to locate and recall all kits in the batch for destruction. – Where are the kits with the bad […]