Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
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Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
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SEARCH JOBSAs the science behind leading-edge therapeutics rapidly evolves, the clinical trials to prove the safety and efficacy of these drugs also become more complex. Biologically derived precision medicines require exact temperatures for shipping and storage and often expire quickly. Also, the kits often have disparate elements, such as multiple vials or prefilled syringes, whose individual volumes must be measured to monitor patient compliance.
The logistics behind getting these therapeutics from manufacturers to sites and patients are complex and risk stock outs or expensive, wasted IP. When closing out a study, manually recording and returning kits and completing patient paperwork is burdensome, causing delays. Sponsors, investigators, and site managers are all motivated to find advanced solutions to the supply chain complexities of today’s clinical trials to accelerate study timelines and reduce waste. Enhanced automation and integrations between systems can simplify these processes and ensure that sites and patients have the drugs they need when they need them.
Manually entering cold chain evaluation data can take days, during which IP supplies at sites can run short or even expire. If a drug has an excursion and requires evaluation, it is quarantined, causing further delays. Rapid, automated temperature excursion management is crucial to de-risking the supply chain. If the IP only has minor excursions, it can be released from quarantine quickly, saving the site costly replacement shipments and ensuring that the drug is available for patients. Automating shipment frequency also reduces the risk of stock outs or wasted buffer stocks. IQVIA IRT utilizes Berlinger temperature loggers, which are the gold standard in cold chain oversight, to provide end-to-end monitoring for improved drug accountability.
Clinical supply managers require precise, real-time temperature excursion tracking to know which kits must be destroyed and, more importantly, which are still viable. It’s no longer sufficient to monitor a lack of excursions only. Today’s trials demand sophisticated trackers that record and report even minute changes, such as compiling data from multiple small excursions to evaluate the drug’s viability. Automated temperature management is essential to safely shipping and storing delicate therapeutics while avoiding unnecessary IP waste.
Berlinger’s SmartView cloud system fully integrates into IQVIA IRT’s data management system, providing detailed temperature monitoring and continuous updates regarding a drug’s status. For example, when a drug arrives at a site, it comes with a temperature logger linked to all kits in the shipment. If multiple boxes have separate loggers, that information is also automatically uploaded into IRT. The drug kits can only be released into the system once their information is uploaded.
Berlinger’s loggers check the data from the shipment to assess if there were any excursions based on the temperature profile of the drug and send those data to IRT. If there was no excursion, then the drugs are immediately released to the site. If an excursion did occur, the program checks any cumulative excursions against the drug’s stability budget to approve or quarantine the kits. Together, Berlinger’s SmartView platform and IQVIA IRT’s system allow end-to-end IP accountability oversight, from shipment to site to managing patient usage to final return or destruction. This continuous flow of information throughout the life cycle of the drug kit ensures quality data and regulatory compliance.
Study managers know that many commonly used data management and reconciliation tools are inadequate for today’s clinical trials. Historically, these tools have been siloed, such as paper logs or digital logs that require manual entry. When siloed, these data also must be transcribed into other systems, which is unnecessarily laborious. Manually managing IP shipments from intake to dispensation to reconciliation is time-consuming and can result in mistakes that impact patient safety or data integrity. Automated, centralized systems reduce time and risk while also creating a seamless patient journey.
IQVIA IRT’s supply automation value engine (SAVE) streamlines these processes by automatically adjusting supply strategies at sites using multiple factors and a myriad of potential tactics. SAVE provides an optimized buffer stock and forecasts patient needs while reducing the number of shipments through continuous monitoring. SAVE also adapts to alterations in trial design, such as the duration of the screening period or changes in patient numbers. These changes affect sites’ supply requirements and SAVE mitigates over-stock or stock-outs without taxing site staff. For example, study designers often over-forecast enrollment and order too much IP. Unused IP is costly, especially when companies factor in shipping costs and sustainability goals. But SAVE’s program routinely adjusts shipment numbers, preventing IP waste.
IQVIA IRT’s custom Mobile IP app is another solution to automating data management. The app enhances data integrity and patient safety by ensuring the right kit goes to the right patient and fosters collaboration between the site and the monitor. The data is continuously recorded and uploaded to IRT’s cloud in real time, creating an accessible record for sites and study teams. The Mobile IP app represents the industry’s movement from “paperless” solutions that are simply digital records of paper forms to high-quality, centralized, automated processes.
Now more than ever, technological and logistical support for trial supply chains must be precise and nimble. More automation means less oversight and fewer mistakes. Real-time, contextual data give sites confidence that their IP will be available and ready for patient use when needed. Reducing IP waste and avoiding stock outs benefits the entire study, including patients. Finally, streamlined solutions allow companies to meet their sustainability goals by reducing their carbon footprint. Cutting-edge tools such as IQVIA IRT’s Mobile IP and SAVE solutions enhance the relationships between sites and monitors, helping companies meet their drug development goals while increasing efficiency.
To learn more about IQVIA’s Interactive Response Technology visit iqvia.com/IRT.
Power your decentralized trial with an agile randomization and trial supply management solution that supports supply flexibility and optimization as well as adaptable direct to patient options.
