Quick Tip: Unscheduled Titration, Unscheduled Resupply, and Predictive Analysis?

Case Studies

A Sponsor recently posed a great question to Veracity Logic: How does your IRT’s (IWR/IVR) predictive resupply algorithm – which analyzes the drug supply needs of each Site based on actual numbers of patients and their certain types of CTMs/dosages – function properly when unscheduled titration and resupply are also allowed for the study?

First: Be sure your IRT system allows sufficient complexity to deal with these situations!
The IRT should permit at least two types of unscheduled visits — unscheduled resupply, typically used to replace lost or missing drug, and unscheduled titration, which allows unanticipated dose level changes.

Managing Drug Returns with IRT

Case Studies, IRT Essentials

Drug accountability and the problems associated with it remain key issues for clinical trial management as we move into 2018.
Using an IRT (IVR/IWR) system to manage the distribution and assignment of investigational product (IP) is now a well established practice. Most IRTs these days also include some method of managing and documenting the return and destruction of IP consistent with federal guidelines which require Sponsors to account for all of their trial’s unused drug.
But IRTs differ in the functionality they offer with regard to accountability.

Just Say No to One-Kit Shipments

Case Studies

The Challenge:

Striking a balance between effective study drug inventory control and efficient management of shipping costs is not always easy when faced with the real-life complexities of clinical trials.

Automated predictive resupply algorithms that help reduce drug waste at clinical sites are now the order of the day for most IRT (IWR/IVR) systems, albeit with varying degrees of effectiveness when it comes to optimizing shipment efficiencies. Even ‘static’ algorithms – e.g., setting a baseline resupply requirement in the system and using alert levels to dictate when to trigger a new shipment—can present complexities with regard to good shipment management.

Direct-to-Subject Shipping

Case Studies

The Challenge:

In order to help meet global enrollment targets, the Sponsor wanted to reduce the number of clinic visits each subject would need to make while still being able to assign drug every week. The goal was to find a way to deliver drug directly to subjects at home, and on a discretionary basis. Additionally, the Sponsor wanted to allow sites/subjects to be able to choose (and change their minds if need be) at a visit level whether to receive drug at home or by visiting the clinical site.

The Veracity Logic Solution:

A Direct-From-Depot option was added to the IRT system for all visits at which direct-to-home shipping would be allowed. At the Site level, the list of Resupply options in which the Site could participate was expanded to include the Direct-to-Subject option. At the Kit level, the system defined whether a particular kit type could be sent direct to Subjects (e.g., run-in kits were excluded from direct-to-subject). When all three key variables – Subject Activity, Site Resupply, and Kits – were in agreement, Direct-to-Subject shipping was enabled. The Subject visit was recorded, and an Activity Notification was sent to the warehouse with a request that the assigned kits be shipped to the subject’s address (on file at the warehouse).

Shipment options could be modified by each clinical site as needed throughout the study by means of a simple configuration change. By these methods, sites were able to easily adjust to the subject’s preferences while boosting enrollment and compliance.

Let Veracity Logic help with your study challenges!

Requesting Shipments …

Case Studies

Shipments, manual or automated, have it your way…

So it’s time to decide what types of shipment requests you’ll use in your clinical trial. There will be crunch times when Manual Requests are essential; other times when system-generated Automatic Requests are optimal (i.e., generating a shipment when a site’s inventory reaches a pre-set level). For some studies, a Predictive approach (modifying resupply based on multiple variables) is desirable to prevent drug wastage and to keep busy sites from running out. And if these decisions weren’t hard enough, sites for which you wish to use the Predictive model vary in key components of the resupply algorithm, for example, the number of days it takes a shipment to arrive from the warehouse. What to do?

Veracity Logic’s IRT is designed to provide maximum flexibility in the options available for shipping study drug.

Just as no two patients are alike, so are no two sites alike—therefore the VLIRT® system allows variation at the site level. For example, sites can vary in:

Whether or not Manual Requests are used
Whether or not Automatic resupply is used
Whether or not Predictive resupply is used
Alert levels for Automatic resupply
The values of predictive variables used to calculate resupply on a ‘need’ basis
The amount of resupply applied to Predictive models

VLIRT® also makes it easy to modify a site’s shipping preferences during the trial. And even sites receiving automatic shipments are given the additional ability to generate manual requests on demand whenever the need arises.

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Context-Sensitive Menus

IRT Essentials

Veracity Logic’s VLIRT® web interface provides users with easy access to view data and a context-sensitive task menu for each record in the report. The task menu presents the users with only those options allowable for the selected record. For example, the task menu for a shipment that has been sent from the regional depot will allow a user to receive the shipment but will not allow the shipment to be sent again.

Complex Warehousing and Regional Depots…

Case Studies


You’ve got a large, complex clinical study to be conducted at 120 sites in 22 countries around the world, with four treatment groups and two ancillary products required for the trial at all locations. Logistics of manufacture and distribution make it clear the most cost-effective solution is to have centralized warehousing in the US for two of the study drugs, in the UK for the other two study drugs, and that all ancillary supplies should best come from a warehouse in Germany! But your current IRT can’t handle the complex shipping and inventory management required for such an array. What to do?

Veracity Logic’s IRT has been designed to accommodate a wide variety of warehousing and distribution scenarios. For the case above, a central warehouse in the US and a central warehouse in the UK could directly supply one another with study drug, while each warehouse then managed the distribution of all four drugs to multiple depots positioned in EU and North America respectively. In addition, a regional depot in Mumbai (supplied by the UK warehouse) would feed clinical sites in India. A warehouse in Germany would be established to handle the distribution of ancillary supplies direct to all depots in all locations, for distribution to sites. The VL IRT Inventory Management module and Shipment modules would keep all the counts and details in sync.

Got a complex scenario for drug distribution?

Manual Shipment Requests: Help, I need more drug…!

Case Studies


Your resupply algorithm for a particular Site has worked very well—until now. This month a generally low-enrolling site has inexplicably had a banner crop of new subjects. The site is running low on study drug. How do you get more drug to them fast?

Veracity Logic’s flexible IRT system allows for unscheduled Manual Shipment Requests on demand. Authorized (unblinded) users can select the Manual Request option from the Shipments page and specify the precise number of each type of drug to be shipped. The IRT notifies the warehouse of the unscheduled order and warehouse personnel use the IRT to advise the site when their order has been sent. When the package arrives and site personnel mark the shipment ‘received’ via the system, the site inventory is updated within the IRT.

With Veracity Logic’s IRT, a project can have both Automatic and Manual Shipment Request capabilities available at a site level for whatever situation might arise.

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