Sites Are Not Created Equal

Case Studies

Problem:

Why try to push a square peg into a round hole? It's an old saw, but a true one: investigator Sites in clinical trials are widely different in their procedures, their facilities, their local challenges, their staff, their suppliers, their idiosyncrasies. How then does a Project Manager (PM) standardize important aspects of the trial -- things like shipping and resupply processes, predictive algorithms, drug sourcing, and more?

Solution:

When selecting an IRT system, be sure to confirm the presence of a solid capacity for specifying important study variables at a Site level. In Veracity Logic's VLIRT® system, for example, the project team can specify a different set of resupply variables for each Site.

Site A may need to factor in only 3 days for a shipment to arrive from a regional depot; Site B may require 6 days for the same delivery.  Site A may require to be restocked using manual requests only, with no deliveries permitted on a Saturday, while Site B may be designated for automatic resupply to a preset baseline level any day of the week, and Site C may require an exclusively predictive approach.  Site A may require resupply directly from a European central depot, while Site B, though in Europe, requires special sourcing from a depot in Southeast Asia.

No problem --- unless your IRT has a one-size-fits-all approach to Site Management.

In Veracity Logic's system, the predictive resupply algorithm allows Site specificity not only in number of days for shipments to arrive but also the following: target number of days of inventory desirable, minimum days between shipments (e.g., to help control wasteage and shipping costs the PM can prohibit shipments from occurring more often than every X days), and the alert level based on Site inventory for triggering a new shipment.

Given differences in local populations, Sites can also be designated as high, medium, or low enrollers which impacts resupply designs. The predictive algorithm for an individual Site can further be configured to include expected screen failure and/or early withdrawal rates.

The moral of the story is make sure that your IRT provides sufficient flexibility to take into account the real-life needs of multiple Sites in each and every clinical trial.

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