Clinical trials are the testing ground for new therapies. Ensuring the supply chains supporting these therapies remain robust is a critical link in the chain between research phases and novel medicines reaching the market. But with the rise of biologics and personalisation in biomanufacturing, new layers of complexity are being piled onto this landscape all the time.
Data from GlobalData’s Clinical Trials database underscores the magnitude of these challenges. Data on trial disruption reveal myriad factors at play; the leading causes of trial stops and cancellations include low accrual rates, poor efficacy and the weak financial positions of clinical trial organisers. All development stages are affected. Such bottlenecks make clear the urgent need for robust supply chain solutions that can reliably mitigate risk and improve efficiency.
Biopharmaceutical companies face unprecedented demands for the safe, efficient and compliant transport of investigational medicinal products (IMPs), many of which are highly sensitive to environmental factors like temperature, light and in some cases even tilt. In response, comprehensive, innovative solutions are hitting the market. The best of these are designed to deliver end-to-end, real-time monitoring for clinical supply chains, enabling instant product release and safeguarding the integrity of cutting-edge therapies as they make the journey from manufacturer to patient.
Technological challenges – and the innovations making a difference
The clinical trial supply chain has always been a complex balancing act between multiple stakeholders, from manufacturers and logistics providers to research sites and regulatory bodies. The development of biologics and personalised therapies, evident in recent examples like Debio 0228 by Debiopharm International, a theranostic pair currently under investigation, has redefined the required standards for the transport and handling of novel therapeutics. Sensitive to environmental conditions and requiring precise handling to maintain efficacy, these therapies call for real-time, uninterrupted oversight that traditional post-delivery data loggers cannot provide.
How are new platforms and technologies addressing these challenges? Consider Berlinger’s SmartSystem. It integrates advanced hardware and software to meet the demands of modern clinical trials. The system’s architecture comprises the SmartMonitor device and the SmartView software, creating a sophisticated end-to-end monitoring system that offers unprecedented real-time insights into the environmental conditions and physical location of shipments. The software and Berlinger SmartSystem Monitors are developed as a system, making them fully compatible throughout the clinical trial process and facilitating automated release of products in 95% of cases.
The SmartMonitor device is equipped with sensors to track temperature, tilt and light exposure, ensuring the physical integrity of the IMPs and detecting any potential mishandling. This setup provides the requisite monitoring that advanced therapies like Debio 0228 need; when even minor environmental deviations can compromise the drug’s efficacy, there is no room for cutting corners. Additionally, the system integrates GPS location tracking, allowing stakeholders to monitor the IMP’s exact location throughout its journey. This is vital for IMPs that need careful timing and precise temperature control.
SmartView, the cloud-based software component of the SmartSystem, serves as the command centre, aggregating and analysing real-time data from multiple devices. SmartView’s three-way integration with Interactive Response Technologies (IRT) and Contract Development and Manufacturing Organizations (CDMOs) ensures a seamless data flow across platforms, minimising the gaps that lead to missing or incomplete data. This integration enables a 100% data upload rate, providing a full and transparent view of shipment status. And automated notifications alert teams to anomalies instantly, enabling rapid decision-making and intervention when necessary. For example, if a shipment deviates from the required temperature range, the system can trigger an alert, allowing logistics teams to initiate a replacement shipment immediately if needed.
It is clear that supply chain disruptions are top of mind for pharmaceutical executives. According to GlobalData’s Company Filings Analytics report for Q1 2024, industry leaders view these challenges as pivotal – ranking higher than even competitive market pressures and regulatory concerns – especially as complex new therapies and global distribution networks introduce additional layers of risk. Berlinger’s SmartSystem directly addresses these issues by providing a solution that makes clinical trial supply chains more transparent and more reliable than ever before.
By implementing a real-time monitoring system like SmartSystem, companies can adopt a proactive approach, enabling anticipation of potential disruptions and swift corrective action before issues escalate. Returning to the Debio 0228 trial, SmartSystem’s automated capabilities were pivotal to its smooth running; they allowed for mitigation of environmental anomalies, ensuring that patient treatment schedules were maintained without delay. Such a supply chain management model both reduces the risk of product wastage and streamlines the clinical trial process.
Futureproofing Clinical Supply Chains
The success of the Debio 0228 trial demonstrates SmartSystem’s potential to reshape pharmaceutical supply chains by providing a complete end-to-end solution that tracks shipments from production to administration. The system’s ability to guarantee the safety and quality of IMPs across the supply chain, combined with the transparency of real-time data, presents a compelling case for broader adoption of such technology.
Pharmaceutical companies know the value of data-driven supply chain solutions in enhancing operational efficiency and risk management. As therapies grow more sophisticated and sensitive, the need for real-time, automated monitoring will only intensify. Strategic partnerships with cold chain management providers like Berlinger empower pharmaceutical companies to meet these demands head-on, protecting the integrity of their products and, by extension, the safety and wellbeing of their patients.
In a global healthcare landscape where the demand for new therapies is accelerating, the role of cutting edge monitoring technology cannot be overstated. The Berlinger-Debiopharm partnership exemplifies the transformative potential of real-time monitoring solutions in safeguarding clinical trials and delivering life-changing therapies to patients. SmartSystem and SmartView represent an innovation-led response to the strategic imperative for change in the industry – one that ensures the next generation of therapies can be administered safely, swiftly and with unwavering integrity. For more detailed information and to learn how your biopharmaceutical company could get SmartSystem up and running, fill in your details and download the whitepaper on this page.
