IN PARTNERSHIP
Business Transformation Services group, which works closely with life sciences companies in addressing the unmet market need for a highly integrated clinical trial supplies solution. Consortium members get together biweekly,
providing deep insights into clinical manufacturing processes, studying traceability, inventory optimisation, and more, and helping guide SAP in building a product for the future. The outcome of the consortium’s efforts is a standardised, smooth integration of clinical studies with drug substance forecasting, manufacturing, kit labelling, and delivery using the SAP Intelligent Clinical Supply Management solution. The features of this integrated clinical platform are: • Comprehensive integration of study planning and study execution
• Smooth and flexible upstream and downstream integration of SAP Intelligent Clinical Supply Management, encompassing clinical research solutions down to dispensing of medical kits to sites and providers in IRT systems
• Full visibility of medical supplies across the supply chain, including third-party-managed depots at the clinical sites
• Integration with logistics service providers to help ensure shorter cycle times and less manual interaction
• Improved compliance management through efficient shipments across borders
• Immediate corrective action in case of discrepancies between planning and execution through the inclusion of scheduling- agreement functions
• Ability to better meet demand with less manual calculations and readjustments due to the optimisation of warehouse processes
• Management of supply chain of clinical trials with less inventory overhead by safely executing the just-in-time deliveries to the clinical sites on time
• Enabling late-stage customisation for clinical labelling and eliminating the repacking costs due to changes in regulations
• Automatic allocation of supply costs to clinical projects and the right text buckets
• Wastage reduction of drug products at execution sites by dispensing and planning products closer to the shelf life expiration
• Enablement of key strategic decisions on planning, forecasting, and delivery of the
74 | Clinical Trial Supply Handbook
drug product by providing real-time visibility of data across multiple systems
• Capabilities such as predictive analytics, which can identify pain points and slip-throughs
• Adopting industry-standard practices for tracking and serialisation of the inventory like GS1
• Establishing a framework to unify clinical and commercial supply chain processes
Clinical supply management vision The vision for SAP Intelligent Clinical Supply Management is to transform the clinical supply process, accommodate new types of clinical trials without system overhauls, allow cross-trial kit shifting and late labelling, streamline supply cycle times, and improve the integrated planning process. This increased planning accuracy and agile reaction to changes will help avoid unnecessary inventory overheads. This means there is an end-to-end process alignment regarding when medical kits are manufactured, when they are shipped to the clinical sites, and when they are dispensed to the patients. Further benefits of the agile supply chain will result from more frequent manufacturing schedules and smaller batches. SAP Intelligent Clinical Supply Management is reinforcing this industry vision through scalable architecture and smooth integration of data flow across various systems. Scalable architecture through cloud and SAP S/4HANA integration will allow trail managers to take advantage of existing clinical trial management system integrations, design study protocols, and forecast drug substances and kits before they’re pushed for execution and delivery. Data lakes enabled by the SAP Business
Technology Platform can integrate AI and ML capabilities with trials data and provide accurate insights on supply chain processes that can speed up trial process, while laying a foundation for the merger of real-world evidence and clinical data. A continuous exchange between SAP’s life sciences team and leading life sciences companies, complemented by hands-on experience of the Business Transformation Services group, will bring this collective vision of a next-generation solution into reality.
Learn more about SAP’s Clinical Supply Management solution at
https://www.sap.com/cmp/dg/na-sap- clinical-trial-supply-management/index. html?campaigncode=CRM-ZM21-XEV-LSCLTLP
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