Discovering Solution Modules & Business Capabilities of SAP Intelligent Clinical Supply Management

SAP Intelligent Clinical Supply Management is a cloud solution that leverages the power of SAP S/4HANA to automate and improve the clinical supplies process and gain better visibility into the status of supplies worldwide.

The solution specifically addresses the critical requirements of blinding and randomization in clinical trials, ensuring that the intricate demands for forecasting, manufacturing, packaging, labeling, and shipping of clinical trial materials are efficiently managed. By doing so, it facilitates the accurate and timely provisioning of these materials across various stages of the clinical trial process.

This innovative solution enhances the precision of planning within the life sciences industry by integrating clinical trial parameters and enrollment rates directly into supply and demand planning processes. Such integration allows for more accurate predictions and adjustments, ultimately ensuring that clinical trials run smoothly and efficiently.

Furthermore, the solution elevates clinical supply processes by supporting a diverse range of new clinical trials and emerging medicines. It provides comprehensive visibility into the global supply status, thereby ensuring that all stakeholders involved in the clinical trial process are well-informed and connected. This integration forms a robust supplies network that not only enhances communication and coordination among stakeholders but also preemptively addresses potential issues such as supply shortages or excess waste. This proactive approach is crucial, especially when enrollment rates fluctuate unexpectedly.

Combining integrated business processes with real-time insights, the solution leverages SAP Intelligent Clinical Supply Management. This synergistic approach harnesses cutting-edge technological advancements in supply chain management from commercial businesses while simultaneously catering to the specific and unique demands of a clinical supply chain. As a result, users benefit from both the latest industry developments and bespoke solutions tailored to the intricacies of clinical trial logistics.

The Study Management module introduces a new master object within SAP that acts as a central connection point for various aspects of clinical study management. This innovative feature serves as the hub where all critical study parameters are defined and managed, ensuring seamless integration and coordination across different functions.

This master object is the repository for a wide range of clinically relevant parameters. These include, but are not limited to, site groups, which categorize the different locations where the clinical trials are conducted; milestones that track significant progress points in the study timeline; enrollment figures that detail the number of participants involved in the clinical trial; treatment groups that define the different cohorts receiving specific interventions; and packaging levels necessary for the logistics of trial materials.

The module further enhances user experience through a comprehensive Study Overview Page. This feature provides a centralized hub for accessing and monitoring critical study details, offering stakeholders an at-a-glance view of progress and key performance indicators.

Another significant capability of the module is its functionality to define complex treatment schedules. Users can create intricate plans for administering treatments, complete with graphical visualization tools that offer a clear and intuitive representation of these schedules.

The module also includes built-in support for various types of clinical studies. This includes titration studies, where doses are gradually adjusted; dose-escalation studies focused on finding the maximum tolerated dose; adaptive studies that allow modifications based on interim results; and platform trials that test multiple treatments simultaneously in a streamlined manner.

For users seeking a more streamlined approach, the module offers an Alternative Lean Study Master option. This simplified setup is designed to facilitate quicker and more straightforward study configurations while retaining essential functionalities.

Additionally, the module features a Genealogy Report capability. This provides a detailed lineage and history of study data, ensuring transparency and traceability of study parameters and any changes made during the trial.

To further aid in the efficient management of studies, the module facilitates master data creation. This ensures that critical data is accurately entered and maintained throughout the study lifecycle, promoting consistency and data integrity.

Finally, the module seamlessly integrates with Clinical Trial Management Systems (CTMS). This integration ensures that all aspects of clinical trial operations are harmonized, from planning and tracking to reporting and compliance, thereby enhancing the overall efficiency and effectiveness of clinical trials.

The Planning and Forecasting module is a sophisticated cloud-based solution designed to streamline and enhance the management of clinical trial logistics. It encompasses a wide range of functionalities that address various aspects of demand forecasting and planning processes.

One of the primary features of this module is its rough demand forecasting functionality. This capability allows users to generate preliminary forecasts for clinical trial materials, providing an initial estimate based on available data and assumptions. This early-stage forecasting is crucial for setting the groundwork for more detailed planning.

The module also supports early planning based on assumptions. Users can input hypothetical scenarios or preliminary data to begin planning for future needs even before final data is available. This proactive approach allows for better preparedness and resource allocation.

In addition to basic forecasting and planning, this module enables advanced planning with cohort functions as well as switching and drop-off functions. This means that users can plan for specific groups of trial participants, accounting for potential changes in group composition due to factors such as treatment switches or participant drop-offs. This level of detail ensures that planning remains accurate and responsive to real-world dynamics.

For those who prefer a more hands-on approach, the module allows for manual adaptation of planning figures. Users can manually adjust enrollment numbers and kit requirements within the system, or alternatively, they can use Excel to make these adjustments. This flexibility ensures that planners can work in the manner that best suits their workflow and needs.

The deterministic calculation for demand planning is another key feature of this module. This functionality calculates demand in a precise and predictable manner, ensuring that supply plans are based on solid data and reliable algorithms.

To support robust planning processes, the module includes the ability to simulate multiple planning scenarios. This simulation capability allows users to explore different scenarios and their potential impacts on supply and demand, helping to identify the optimal strategy for various situations.

An integrated algorithm connected with Interactive Response Technology (IRT) further enhances the module's functionality. This algorithm takes into account actual enrollment numbers, participant drop-offs, and visit confirmations, providing real-time adjustments to planning figures. This integration ensures that the planning process remains dynamic and closely aligned with the evolving realities of the clinical trial.

The module also supports supply pooling across studies. This feature allows for the aggregation of supplies needed for multiple studies, optimizing inventory management and reducing waste.

Finally, the module seamlessly integrates with SAP supply planning tools. This integration ensures that all planning and forecasting activities are harmonized with broader supply chain management processes, resulting in a more cohesive and efficient approach to managing clinical trial materials.

Overall, the Planning and Forecasting module provides a comprehensive, flexible, and dynamic solution for managing the complex logistics of clinical trials, ensuring that all aspects of demand forecasting and supply planning are meticulously accounted for.

The Manufacturing and Packaging module is a specialized add-on for the SAP S/4HANA system, designed to cater to the unique requirements of clinical trial supply chains. This module integrates several advanced functionalities aimed at optimizing the manufacturing and packaging processes for clinical materials.

One of the primary features of this module is its treatment-specific blinding capability. This ensures that the treatments administered during clinical trials are blinded as per the specific requirements of the study. This functionality maintains the integrity of the study by preventing bias and ensuring that neither the participants nor the researchers know which treatment is being administered.

The module includes clinical-specific serialization enhancements. Serialization is critical for tracking and tracing pharmaceutical products, and the enhancements provided by this module ensure that serialization processes meet the stringent requirements of clinical trials, ensuring both compliance and traceability.

Integration and collaboration with Contract Manufacturing Organizations (CMOs) is another key functionality. This feature facilitates seamless interaction with CMOs, ensuring that the manufacturing of clinical trial supplies is efficient and coordinated. By streamlining communication and data sharing, this integration helps to maintain quality and timelines in the production process.

The module offers robust management of medication kit lists. This functionality enables efficient tracking and management of medication kits required for clinical trials, ensuring that all necessary supplies are readily available and accurately accounted for.

Shelf-life extension management is another critical feature provided by the module. Clinical trial materials often require extended shelf lives due to the extended duration of studies. This feature helps manage and extend the shelf life of materials to ensure they remain viable throughout the trial period.

The management of expiry dates and country-specific shelf-life requirements is also supported. This ensures that clinical materials are compliant with regulatory requirements in different countries, preventing the use of expired or non-compliant products in clinical trials.

System-supported batch allocation and the calculation of use-by-dates for blinding groups is another advanced functionality offered by the module. This feature ensures that batches of clinical materials are allocated and managed effectively, with accurate tracking of use-by dates to maintain the integrity of blinding in the trial.

The Master Data Monitor feature checks the readiness of materials for packaging. This functionality ensures that all necessary data and preparatory steps are in place before the packaging process begins, reducing the risk of errors and delays.

Lastly, the module includes specific labeling enhancements within SAP Intelligent Clinical Supply Management. These enhancements ensure that labeling processes meet the specific needs of clinical trials, including regulatory compliance and accurate information dissemination.

In summary, the Manufacturing and Packaging module for SAP S/4HANA provides a comprehensive and specialized set of tools designed to optimize the production, management, and packaging of clinical trial materials. It ensures compliance, efficiency, and integrity in the supply of clinical trial products, enabling successful and smooth trial operations.

The Distribution module is an advanced add-on for the SAP S/4HANA system, meticulously designed to manage the complex logistics and distribution needs of clinical trials. This module encompasses several critical functionalities to ensure the efficient and compliant distribution of clinical trial materials.

One of the primary features of this module is the comprehensive management of distribution logistics, covering the entire journey from production facilities to depots and ultimately to clinical sites. This end-to-end tracking ensures that clinical trial materials are consistently handled, monitored, and delivered accurately to their intended destinations, maintaining the integrity and efficiency of the supply chain.

The module also supports bundling and cross-study pooling. This functionality allows clinical trial materials to be aggregated for multiple studies, optimizing inventory management and reducing overall costs. By pooling resources, the module enhances the flexibility and efficiency of distribution across various clinical trials.

Another vital feature is site stock visibility. This allows stakeholders to have real-time insight into the stock levels at different clinical trial sites. This visibility ensures that inventory is adequately managed, preventing shortages and overstock situations that can disrupt trial operations.

The module provides detailed dispensing information, which tracks the distribution and usage of clinical trial materials at the site level. This ensures that dispensing actions are recorded accurately, contributing to compliance and precise tracking of material use.

Kit destruction tracking is another crucial feature. This functionality ensures that the destruction of clinical trial kits is adequately documented and managed, complying with regulatory requirements and maintaining the integrity of the trial.

Returns management is efficiently handled within the module, facilitating the process of managing returned clinical materials. This includes tracking, documentation, and appropriate handling of returned items, ensuring that they are managed in compliance with regulatory guidelines.

The module also includes expiry lead time validation. This functionality verifies that clinical materials reach their destinations within their valid shelf life, thereby preventing the use of expired products and ensuring the safety and validity of the clinical trials.

Integration with Interactive Response Technology (IRT) further enhances the module's capabilities. This integration allows real-time data sharing and synchronization with IRT systems, ensuring that enrollment, dispensing, and visit information are accurately reflected in the distribution processes.

The module supports integration with Third-Party Logistics Providers (3PLs), facilitating seamless collaboration with external logistics partners. This integration ensures that the entire distribution process, including transportation and warehousing managed by 3PLs, is efficiently coordinated and monitored.

Lastly, the module adheres to Global Standards 1 (GS1) standards, ensuring that all distribution activities comply with internationally recognized guidelines for traceability, labeling, and data sharing. This compliance aids in maintaining high standards of quality and consistency across the distribution network.

In summary, the Distribution module for SAP S/4HANA provides a comprehensive suite of tools for managing the distribution logistics of clinical trial materials. It ensures efficient and compliant handling from production to clinical sites, offering functionalities such as bundling, site stock visibility, dispensing tracking, kit destruction, returns management, expiry validation, and seamless integration with IRT and 3PLs, all while adhering to GS1 standards. This module significantly enhances the reliability and efficiency of distributing clinical trial materials across the globe.

The blue and green boxes in this process flow indicate the business functionality delivered by the four modules of SAP Intelligent Clinical Supply Management.

Other boxes represent the functionality delivered by other solutions that Intelligent Clinical Supply Management integrates with.

Working in conjunction with the customer's CTMS and IRT systems, Intelligent Clinical Supply Management is used for:

• Study set-up as per the defined requirements
• Demand planning for the clinical trial
• Manufacturing, packaging, and labeling of clinical medication as per the requirements at various sites
• Distribution of clinical medications across sites as per the planned requirements