Clinical supply & logistics


Digitalising in action It’s clear that the digitalisation of clinical trial supply chain management has emerged as a game-changing solution. Be it integrating digital tools, data-driven insights, and automation, companies can transform their operations to achieve unparalleled levels of visibility, efficiency, and collaboration. To illustrate the impact of digitalisation, consider a global temperature- sensitive oncology clinical trial, involving over 100 sites across multiple continents. Traditional supply chain management methods would typically lead to frequent stockouts, excessive wastage and compliance challenges. However, after implementing digital solutions, not only is it possible for stakeholders to see real-time monitoring, but also enhanced forecasting if AI-driven models are used. As well as this, streamlined logistics can ensure faster customs clearance and improved on-time delivery to sites. Digitalisation offers a comprehensive solution to these issues by introducing end-to-end visibility, predictive analytics, and automation. Through real-time tracking and monitoring tools, stakeholders gain unprecedented transparency into the supply chain. For instance, Internet of Things (IoT) sensors can monitor the conditions of temperature-sensitive products throughout transit, immediately alerting operators if conditions deviate from acceptable parameters. Beyond basic real-time monitoring, IoT technology is evolving to offer predictive capabilities. Sensors now come equipped with advanced analytics to identify patterns that may indicate future risks, such as minor temperature fluctuations that precede full-blown excursions. This pre-emptive capability transforms supply chain management from reactive to proactive.


Digital clinical supply chain


Cloud-enabled digital core Integrated planning and execution solution or data hub model to enable leading capabilities, practices, and insights


Analytics-driven performance Insights lead to actions: Orchestrate activities across the value chain; align performance and status to KPIs


Blockchain-based product track and trace


Faster trial outcomes Optimised trial supply


IoT-powered, real-time quality monitoring


Constant monitoring during shipping and storage to provide temperature excursion alerts and patient adherence information


Source: Deloitte Clinical Trials Insight / www.worldpharmaceuticals.net 25


Enhanced regulatory compliance


Secure insight to product movement at the finished good and batch level, and audit trail to enhance regulatory compliance


Biopharma industry trends create challenges for clinical supply chains


■ Full traceability of clinical supplies: End-to-end finished goods traceability is needed at the trial, program, CMO, and geography levels


■ Regulatory complexity and varied trial designs: Regulatory changes, import/export rules, and expiry date requirements create regional complexities to manage and adapt operations. Evolving trial models, such as direct-to-patient, adaptive designs, and the push to faster trials drive additional clinical supply requirements


■ Increased externalisation: Increased reliance on external partners drives integration and standardisation challenges required for achieving orchestration capabilities


■ Next-gen advanced therapies: New drug modalities, including gene and cell therapy, create additional implications due to their unique and evolving requirements


■ Increasing cost pressures: Cost management expectations exceed capabilities for managing and continually improving cost performance


Source: Deloitte


Similarly, blockchain technology enhances traceability by providing an immutable record of every transaction and movement, ensuring that all parties can verify the integrity of the supply chain at every stage. Through its decentralised ledger system, blockchain ensure that every transaction, from production to delivery, is securely recorded and easily auditable. Predictive analytics, powered by artificial intelligence (AI) and machine learning, represent another cornerstone of digital supply chain optimisation. These advanced tools enable organisations to forecast demand more accurately by analysing historical data, patient recruitment rates, and trial protocols. But what role will predictive analytics play in optimising the supply chain? “To put it simply, we use predictive analytics to minimise surprises in the supply chain and reduce the need for firefighting,” explains Erika Biggadike, head of supply chain at 4C Associates.


Mobile-centric digital patient experience


Simplify and streamline clinical label management and allow for improved patient experience and insights


Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20  |  Page 21  |  Page 22  |  Page 23  |  Page 24  |  Page 25  |  Page 26  |  Page 27  |  Page 28  |  Page 29  |  Page 30  |  Page 31  |  Page 32  |  Page 33  |  Page 34  |  Page 35  |  Page 36  |  Page 37