Putting Drug Where It’s Needed Most

Case Studies

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

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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 ‘no-brainers’, not demanding much forethought or attention. But it takes only one or two experiences in a complex trial for Clinical Project Managers (PMs) to concede that developing and managing processes for ordering, reordering, controlling limits on the amount ordered, and managing the users authorized to order supplemental materials is an important part of the efficient – and painless– execution of a clinical study.

Ten Areas to Find ROI From Your IRT System …

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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 pricing pressure. A demonstrable ROI – Return on Investment – is therefore a minimum requirement when considering whether a particular service provider is a worthy addition to the project mix.

Use of Quarantine Strategies to Leverage Investigational Product

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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?

Using Enrollment Thresholds

Case Studies

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 miss enrollment opportunities that cause study delays as a result. How can your IRT (IWRS/IVRS) system help?

Solution: Veracity Logic’s VLIRT® system allows clients to assign individual enrollment thresholds for each site in the study. A site can be defined as a Low, Medium, or High enroller based on best industry information at the onset of the trial. Each enrollment level feeds into the study’s resupply and inventory management algorithms to determine the optimal amounts of drug to be provided to the site – at initial shipment, for baseline maintenance, and in terms of resupply alert levels for study drug. Recognizing that the one firm rule of clinical trials is that change will occur, enrollment thresholds in the VLIRT® system are easily configurable throughout the study – threshold designation can be changed by Project Managers as events dictate at any point in the trial without requiring custom coding or vendor involvement.

The application of enrollment thresholds is particularly useful when the design of the study doesn’t permit the use of predictive resupply functionality. Predictive resupply is not always a good option for low numbers of users and dosing visits, nor for studies where visits are too close together to handle a just-in-time approach to shipping. In such cases, enrollment thresholds can help project managers put study drug where it will do the most good throughout the trial.

Tracking Temperature Deviations…

Case Studies

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 and the clinical site. Great! But what about the IRT’s inventory tracking? How does it know to hold that drug? And what to do with it next?
Solution:

When the site receives the shipment, they will have to answer the question, “Did the shipment experience a temperature excursion?” before being able to proceed. If yes, Veracity Logic’s IRT gives you the power to make important decisions:

You can specify which types of temperature excursions occurred – i.e., ambient, refrigerated, frozen, or all three.
You can specify whether some or all of the kits in the shipment were affected.
After reviewing the temperature excursion details, you can decide to reinstate a kit or a shipment and make it once again ‘available’ for assignment to subjects.
Conversely, you can quarantine the kit or shipment after reviewing the deviation details. Quarantined kits will remain unavailable for assignment and will automatically be replaced in inventory in the next shipment.
You can designate kits and shipments for destruction or for return to the warehouse.

In other words, Veracity Logic’s IRT gives you the flexibility to meet real-life scenarios with real-life solutions.

Reporting Problems with Kits…

Case Studies

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 to be helpful, stuck an ambient study drug into the fridge to keep it cool.
Site 101 has a record of Kit 702 having been received but Site personnel can’t find it on the shelf.
And the kit that was supposed to go to Subject C was distributed to Subject D by mistake! What to do?

Solution:

With Veracity Logic’s IRT managing your study drug distribution these unexpected events are easily dealt with and documented. Users select Report Problem from the Task Menu of the selected kit and with a single click record the details of Damaged, Missing, Temperature Deviation, or Misadministered kit. The Inventory page automatically reflects changes in kit status. Flexible functionality allows kit statuses to be modified yet again when problems are resolved, such as, when a missing kit is found or a temperature deviation is determined to be within acceptable parameters. The inventory-control functionality of Veracity Logic’s IRT system ensures you will always know the current status of each site’s inventory and the whereabouts of each individual kit in the study.

Want to know more about the powerful standard offerings of Veracity Logic’s IRT?

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

Case Studies

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 quick and efficient way for each clinical site to document these returns throughout the study. How to do it?
Solution:

With Veracity Logic’s IRT, drug accountability is easily managed. Users chose Return Kit from the Task Menu of the selected kit; the system prompts the user to record the counts of the units Used and Returned. The system then determines if there are any units ‘unaccounted for’ in the kit. Standard functionality guides the process with edit checks to make sure the counts entered are consistent with the amount of drug originally dispensed. The use of the IRT to document drug returns ensures standardization of the drug accountability process across sites. And with Veracity Logic’s capability for easy system configuration, the modification of return functionality to suit your protocol needs is achieved with limited impact on timelines.

Want to know more about the powerful standard offerings of Veracity Logic’s IRT?

Product Recall

Case Studies

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 drug?
– Are there any already shipped to clinical sites?
– Any, heaven forbid, assigned to subjects?

Leverage IRT Capabilities for Clinical Supply

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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 with Clinical Supply Teams to ensure a seamless interface with project packaging and delivery strategies. We’ve integrated with supply teams from companies like PCI, Almac, Thermo Fisher and more … and we easily do the same with any new supplier. Use IRT to simplify the following processes: Inventory Control, JIT Shipping, Return and Destroy Options, Warehouse and Depot Relationships and Temperature Deviation Tracking which are all included in Veracity Logic’s performance capabilities for your project.