In a recent Clinical Leader Live webinar, Leveling Up Supply Chain Initiatives To Ensure Accountability, Sustainability, And Optimization In IP Management, expert panelists Maxime Schuchewytsch, Associate Product Management Director at IQVIA IRT; Jeremy Star, Product Manager at IQVIA IRT; and Jonathan Walter, Associate Director of Business Operations and Capabilities at IQVIA discuss how to streamline shipments, reduce waste, and provide greater drug accountability. A Q&A session followed, in which the panelists shared their best practices for optimizing supply chain logistics.

Q: What are the best methods to record temperatures during IP shipments, and how can these records be maintained centrally?

Star: We use Berlinger temperature loggers, each shipment can be associated with one individual logger, or multiple loggers. If the shipment is particularly large, you can record all kits into one logger or track them separately on different loggers to monitor them simultaneously and continuously. In the past, we recommended that data be recorded manually into another system, but the advantage of our current integration is that the files can be automatically uploaded, and data is captured centrally. This reduces the risk of manual error.

Our current system also saves the time it would take to manually record and evaluate the data because these are happening automatically. Another advantage is if the kits are involved in more than one shipment, e.g., they’ve gone from one depot to another and then to a site, we have the data from both movements captured centrally. We can evaluate those kits based on both shipments. For example, say some of the temperature captured in the first shipment was slightly outside the acceptable range but not by a huge amount. Then if the second shipment was also slightly off, the system puts them together to alert us that an excursion has happened and if the total duration of both excursions is beyond acceptable limits, this will mean the kits are no longer safe. Using that automatic process allows us to conduct evaluations as quickly as possible.

At some point in the future, rather than uploading the files automatically when the shipment arrives at the destination, that data could be transferred to the system during shipment. In that case, it could be sent via any communication system to send the data and calculate it in real time. We wouldn’t have to wait for the shipment to arrive at the site. If we knew there was an excursion, we would know what kits were no longer suitable. We could anticipate that and set up replacement shipments, reducing the risk of short-stocking sites.

Q: Can the sponsor’s QA group be used instead of Berlinger?

Star: First, we expect the sponsor’s QA group to be involved in determining the rules for each medication type, its storage limits, and its temperature requirements. There should be sponsor input into those criteria, and we would expect them to review the requirements throughout the trial to see if those limits are still accurate or need to be adjusted before determining whether they should be involved instead of Berlinger. We certainly can’t force sponsors to use Berlinger. There are plenty of trials out there already where we’re not using Berlinger, and decisions still need to be made on the viability of the drug following temperature excursions.

Whether the sponsor uses Berlinger’s devices or another system, we still have retrievable data on those devices needed for decision-making. In Berlinger devices we have two files. One needs to be uploaded into the system because its data is in a machine-readable format, but we also have a PDF version that is easier for people to read. The sponsor’s QA group could be involved, and even if Berlinger determines that the drug is out of its stability budget based on the rules provided, the QA group may look at the data and decide that the drug is still viable after all.

And so, the QA group can be involved at every stage, whether Berlinger is used or not. We don’t force anybody down a particular route. However, having the automatic calculation done by Berlinger is advantageous because it is very swift. It uses all the available data, so it’s beneficial to avoid needing to do manual checks, but additional oversight is allowable.

Q: What are the opportunities for supply flexibility with the SAVE program at IQVIA, such as a drug program-wide IRT build instead of study-specific IRT builds where the drug can be used, where needed, across an entire research program?

Schuchewytsch: Adding flexibility does create less waste. This question is linked to the pooling of medication across the program, which we’ve already delivered at IQVIA as part of our standard IRT platform. Now, would SAVE be able to support these? Absolutely. We’ve been working recently to embed SAVE into our core platform to bring more flexibility and configurability. So yes, we could adjust that to support a study program where medication would be pooled. It’s more a matter of where the module is looking to retrieve the data, but the engine to support that flexibility and innovative supply is already there.

Q: What are the latest innovations happening in IP management? Also, how can we, as a project team, better understand what happens to shipments once they are shipped to the site with less manual oversight?

Schuchewytsch: IP management, in general, is a broad topic, and there are many domains in which innovations are being presented. Whether it’s about clinical systems, labeling and packaging, tracking and tracing, direct-to-patient, advanced therapeutics, distribution, storage, or savings, as well as supply and forecasting, there are numerous options. The question we must answer is how technology can support better accountability. At IQVIA, we’re investing in many different domains. For example, with labeling, we’re using QR code scanning and working on standardizing the metadata embedded within the QR codes so applications such as mobile IP can use them.

Another technology for tracking and tracing kits is using shippers’ publicly exposed APIs to get shipment information in real time. It’s similar to shipping a parcel at the post office. You can track your parcel in real time, but it’s not something that the industry has fully adopted when it comes to clinical shipments. These tasks are still very siloed. More integration is needed. Also, dispensing and forecasting can be improved because of the new and advanced technologies being developed.

We also see the increased use of wearable devices that gather patient data as having the potential to improve IP management. Devices like fitness trackers or smartwatches that collect patient data are becoming increasingly important, and the better the data, the better the predictions for supply. Most importantly, AI and machine learning are becoming essential in clinical trials because they can analyze large amounts of data and predict outcomes. So, whether it’s identifying potential trial participants or anticipating patient responses to treatment, machine learning can make clinical trials more efficient and effective.

These tools can also automate routine tasks, freeing up time and resources that can be diverted to other aspects of the trial, including IP management in IRT. We’ve demoed Mobile IP which uses a machine learning model and SAVE will use AI in the future. So, AI can be used in many aspects of IP management and other trial aspects, including protocol design, electronic case report forms, design, medical coding, query management, or chatbot topics.

Q: What does an industry best-practice, drug accountability program look like?

Walter: First, we break down silos of information for documentation and practices through standard interoperable integrations that connect to IQVIA IRT. Next, we bring automation and intuitive workflows to the site to document the site’s activities. The site is documenting its process as it works within mobile IP so that it’s seamless, intuitive, and centralized. This streamlined data and activity is available within IRT. After they’ve completed a report, they can pull it, download it, and it becomes their accountability log if needed. The IRT also provides CROs with remote monitoring.

Q: How does the clinical supply manager know the plan for more IPs being required if SAVE automatically starts sending out more drug kits?

Schuchewytsch: The supply strategies are based on what is currently available, according to the data in the system and the materials available at the depot. If more needs to be planned initially, we will adjust the strategies. SAVE is not a supply planning tool per se, but it changes the system based on data. With AI in the future, we can gather more data and adjust our strategy even further.

Q: What real-time control metrics do you consider most important? 

Schuchewytsch:  The use of real-time data does support easy and complete oversight of your trial, but when it comes to identifying the most significant control metrics, you’ll find they are often intertwined and dependent on study role. For example, control metrics on real-time enrollment are critical for study managers and supply managers who must plan IP releases. Similarly, real-time data on shipments from distribution vendors are essential to supply managers, receiving sites, and patients visiting on a set date to ensure on-time dispensing. IRT is a central and critical system, and prioritizing the data or metrics takes work. That said, real-time metrics on shipments (tracking drug orders), depot and site stocks, and temperature excursions are considered critical.

Q: What strategies are you considering for integrating digital systems to create seamless digital data flow?

Schuchewytsch: The strategy we are considering for digital system integration is making the trial more “human-centric” and decentralized. Now, this can impact the patient journey and material accountability. Many systems can be involved in this process, but when it comes to IRT, we are looking at where the patient journey starts and what data is relevant to make it as smooth as possible. As IRT is involved in the screening, randomization, dispensing, and drug accountability processes, IQVIA offers a complete suite of systems for patient engagement that we can integrate. IQVIA IRT is set up to integrate with our eConsent and eCOA solutions, enabling enrollment in the study and dispensing of drugs in IRT with a direct feed from these systems and, eventually, reducing data input for the sites and patients. 

Also, from a material management perspective, we have implemented standard integrations with distribution vendors to automate drug orders and shipments for each study. Integrations using the latest technologies are enormous steps forward to make the data flow as seamless as possible. Finally, I can say that IQVIA is heavily investing in centralizing access to the various eClinical systems involved in the trials so that the life of the sites will be more accessible than ever before. The idea is that they will find all the relevant data and accesses (IRT, eCOA, EDC, eConsent, labs, etc.) under one generic portal, drastically simplifying the level of oversight required from investigators, CRAs, supply managers, and study teams.