Providing drug supply support in complex environments through IRT

Stefan Duerr, sr. director, head of the Cenduit Drug Supply Center of Excellence, and IQVIA business, explains how a flexible and innovative approach to Interactive Response Technology (IRT) can help navigate today's clinical trial landscape.

Key insights:

• An adaptable IRT solution can provide optimal support for everchanging trial supply chain strategies.
• Real-time IRT data is critical to creating predictive analytics and proactive measures to help sponsors optimise supply chains to manage costs and meet sustainability goals.  
• Having the right IRT partner can assist in precise supply chain modeling and forecasting, and the automation of supply strategies based on real-time trial data.

Interactive Response Technology (IRT) is a powerful tool for managing mission-critical study information, including patient recruitment, drop-out rates, visits and drug supply. Clinical studies have become more complex and data-driven over the years, leading to an increasing need to improve how IRT data can be used in clinical trials. In today's clinical trial landscape, IRT systems must be flexible and innovative. Sponsors, sites, and patients must be able to execute life-saving clinical trials with flexibility. As part of an IRT study design, enrollment numbers, cohorts, visit schedules and dosing schema often change– but an adaptable IRT solution can provide optimal support for everchanging trial supply chain strategies.

Real-time IRT data is critical to creating predictive analytics and proactive measures to help sponsors optimise supply chains to manage costs and meet sustainability goals.  Therefore, it is critical that IRT be leveraged to apply the most up-to-date data in a way that re-evaluates and assigns the most optimal supply strategy for each site in real-time. The use of real-time IRT data makes it possible for intelligent supply chain optimisation to be automatically configured, reducing risk, waste, cost and effort while reducing clinical team effort during a study.

Many factors need to be considered to ensure each patient receives the proper medications during a dose visit. A strong IRT technology partner helps balance these factors to minimise the number of costly shipments that need to be made.

In the past, to avoid IP stock-outs and a subsequent trial pause or failure, the safest protocol for assigning clinical supply often included over-forecasting and over-supplying IP by almost 200%.  This leads to significant IP waste, excessive shipping costs and erodes sustainability goals. Now more than ever, the optimisation of a trial’s supply chain through technological or logistical support must be precise and nimble.  Sponsors can meet sustainability goals by reducing shipments and IP waste while also reducing overall trial supply costs and improving timelines with intelligent resupply optimisation.

Why it matters: the benefits of drug supply technology

When optimising your clinical supply, it is crucial to engage a technology partner specialising in tools and services geared toward both your trial supply and sustainability goals.  The sharp rise in gas prices and resulting high inflation make reducing shipping and energy costs an economic imperative.  Additionally, the limited availability of drugs and API resources, expensive comparator drugs, sensitive compounds, short IP expiration dates, as well as high volumes of deliveries introduce logistical challenges and increase cost pressure.

Today’s trial supply challenges have been expanded to include new and unique factors such as a 250% increase in container costs, a 100% to 200% increase in API precursors as well as inflated fuel costs – such as a 139% in natural gas prices. Many trials are experiencing shortages in raw materials and labour – making conservation of effort and supplies essential.

It is essential to engage the right IRT partner to assist in precise supply chain modeling and forecasting, the automation of supply strategies based on real-time trial data as well as deep partnerships in global logistics.

Factors your IRT partner should address:

• Concrete ways to reduce clinical supply costs - Utilising the right forecasting tools, resupply algorithms and proprietary optimisation tools reduces drug wastage and shipping costs for clients. Online forecasting dashboards and other tools should provide a view into future depot stock trends based on real-time data and future recruitment plans that consider site numbers, real time patient counts and recruitment goals.
• Technology that reduces burden and manual work - By automating supply strategy, supply management becomes easier and most cost-effective. Automated tools should reduce the burden on sponsors and drug supply managers while optimising the supply chain.
• Complexity management - To ensure patients receive the right drug at the right time, in the right place, complex study protocols require new methods for managing the clinical drug supply chain.
• Fewer replacement shipments - With early replacement logic and automated resupply optimisation within IRT, replacement shipments can be eliminated and reduce shipment backlog.  This saves on shipping costs and boost sustainability goals.
• Strategies to optimisation expensive IP or comparator costs - Managing comparator drug stocks using automated resupply optimisation through IRT reduces comparator costs.
• Plans that eliminate site stock-out potential - It is essential to set up study-specific supply strategies that forecast patient and site needs using real-time data to ensure every patient receives the right drug at the right time. As more study data is available, regular data reviews are used to improve the study.

Staying prepared for the future: Empowering your resupply optimisation strategy

Considering that clinical studies are likely to become more complex and data-driven in the future, it will become even more critical to improve the effective use of IRT data. To navigate the modern clinical trial landscape effectively, you need to partner with a provider who offers both a high-quality system and strong drug supply expertise with innovative technology.