CTM MANAGMENT

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
RELATED POSTS
  • Case StudiesAug 29

    Putting Drug Where It’s Needed Most

    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. +

  • Managing Supplemental Supplies with your IRT

    Required Non-Investigational Materials It doesn’t seem like a big deal until you have to do it – managing the bandages, syringes, saline solution, tubing, and so on, that Sites may require during the conduct of your clinical trial. The non-investigational materials required for use at clinic visits are often regarded as +

  • Ten Areas to Find ROI From Your IRT System …

    Conducting a clinical trial – even a small one – is expensive. Pressure to contain costs is a constant presence in the lives of procurement managers, project managers, and senior personnel in all operational areas of Sponsor-companies and CROs. Accordingly, vendors who serve the pharmaceutical industry also live under intense +

  • Use of Quarantine Strategies to Leverage Investigational Product

    Challenge: The cost of producing an adequate store of investigational drug for a clinical trial remains high – significant enough that new ways to forecast manufacturing quantities, predict optimal shipping schedules, and differentially assign drug to sites based on enrollment estimates are constantly being developed. How might IRT systems provide additional methods +

  • Case StudiesApr 18

    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 +

  • Tracking Temperature Deviations…

    Yikes, someone left the package out in the heat! Problem: Your drug must remain within a set temperature range at all times. How are you going to ensure drug that experiences a temperature deviation is not distributed to subjects? Your packaging and transport vendor(s) will record temperature deviations that occur between the manufacturer +

  • Case StudiesOct 18

    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 +

  • Case StudiesOct 11

    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 +

  • Case StudiesAug 11

    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 +

  • Leverage IRT Capabilities for Clinical Supply

    IRT systems deliver a wide range of applications for managing patient interactions and drug supplies throughout the clinical trial lifecycle. Serving sponsors, drug suppliers, and clinical sites, IRTs remain your best bet for subject randomization, drug assignment and product inventory management. Seamless Interface Makes For a Satisfied Client Veracity Logic works closely +