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.

Temperature Deviation and IRT

IRT Essentials

The ability to track the temperature excursions of an investigational product has taken on an increasing importance in clinical trials. Temp tales and similar devices are used to record the drug’s environmental exposure from the time it is sealed into a shipping container at the warehouse to the time it is unpacked at a clinical site. The electronically recorded temperature history is available for review by project teams and site personnel on demand.

A robust IRT (IVR/IWR) must be able to take into consideration the real-life, logistical issues associated with the issue of temperature deviation, whether ambient, refrigerated, or frozen.

Managing Drug With IRT

Case Studies, IRT Essentials

When selecting an IRT (IVR/IWR) system for your clinical trial, what features should it have to ensure you can adequately manage the critical but logistically complicated world of study drug?

Here’s a quick checklist of things to consider:

Ability to have ‘at-a-glance’ access to information relevant to study drug– for example, in a straightforward table view – without the need for complicated querying, and with the ability to deliver or withhold types of information based on user roles. An at-a-glance view should include:

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

Newsletter Archive

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 …

Newsletter Archive

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

Newsletter Archive

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.