Use of Quarantine Strategies to Leverage Investigational Product

InventoryUser-Management

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 of minimizing drug waste during a study?

Solution:

Veracity Logic’s VLIRT® CORE functionality offers another way to optimize study drug management, in addition to the above, in the realm of temperature deviations. Instead of having the IRT system deal with reported temperature excursions by simply removing the potentially damaged drug from the site assignment roster, the drug is moved into temporary quarantine – a holding bin that permits, for example, authorized study personnel to review the details of the excursion and compare them to the latest guidelines for product viability.

Authorized users can decide whether to remove the unit from the study, or whether circumstances permit its status to be updated so that it can be assigned to subjects. In addition to instances of temperature deviation, the use of a quarantine strategy can provide broad-spectrum control for a wide variety of oversight functions relating to the proper handling and use of investigational product. For example, the project system can be set to require that ALL drug be placed in quarantine when first received at a clinical site, and a pre-set, quality-confirmation and release process be applied by the project manager (or a different authorized user). Many other variations on the Quarantine strategy can be adapted to meet the specific concerns of the clinical study.

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