Over the last two decades, several trends in clinical research have led to increasingly complex and expensive clinical trials. A recent study revealed that phase II clinical trials have produced an increase of 61% in the mean nominal cost per study volunteer visit within a period of ten years. Clinical trials now have more endpoints, more complex eligibility criteria, more protocol amendments, and more clinical sites. A central reason for this complexity is the trend towards more personalized medicines:  

• Patients are stratified according to different molecular criteria before being enrolled in a clinical trial, which requires patients from around the globe and individualized drugs in small quantities.
• With biologics on the rise in many R&D pipelines, special handling and cold chain solutions are required to safely ship and distribute these temperature sensitive reagents to the various clinical sites.
• Very often, the short-lived nature of these compounds even requires just-in-time shipment, further complicating the supply chain.  

All these factors combined with import/export regulations for the different participating countries result in an extremely challenging task for all clinical supply chain professionals. Thus, reliable logistics and clinical distribution are becoming more and more mission-critical when it comes to the creation of efficient and calculable patient-centric clinical trials.  

Ideally, the end-to-end clinical distribution process is also reflected in the software solutions, considering all the requirements for an effective warehouse management process, intra-network distribution, and the provisioning of a site-level inventory. However, software solutions on the market often are highly fragmented and not integrated with each other, therefore still requiring failure-prone and elaborate manual handover processes.  

SAP and Tenthpin, together with an industry consortium led by Roche have risen to this challenge and developed an SAP industry standard software solution: SAP Intelligent Clinical Supply Management. The solution consists of several modules covering the whole clinical supply chain process: from study management to planning and forecasting, manufacturing and packaging, and distribution and dispensing of the medication to the study subject.  

The current blog series has already given an overview of the first three modules of SAP Intelligent Clinical Supply Management (linked in the previous paragraph) and highlighted the key differentiators of the solution. This last chapter will conclude the series by introducing the distribution module in more detail.  

Clinical Distribution with SAP Intelligent Clinical Supply Management  

The Distribution module is part of an SAP S/4HANA add-on supporting distribution from production to depot as well as from depot to the clinical site guaranteeing continuous site-stock visibility.  

The add-on leverages existing SAP business capabilities and solutions such as material management, production process, logistics, sales, global label management, SAP Extended Warehouse Management, SAP Advanced Track and Trace for Pharmaceuticals, and SAP Global Trade Services. Thus, it is not only essential for warehouse management and site-level inventory, but also for intra-network distribution and clinical site shipment. Here, it also helps to ensure import license and trade compliance.  

Within this scope, many existing components of SAP S/4HANA have been enhanced by functionalities that are specific to clinical trials, thus guaranteeing seamless integration of clinical distribution processes into related standard business processes.  

The following paragraphs illustrate the functions that have been enhanced for the SAP Intelligent Clinical Supply Management distribution module in more detail: 

Master data enhancement  

SAP Intelligent Clinical Supply Management includes a master data foundation to support clinical manufacturing and distribution. For example, the business partner interface has been extended based on the integration of existing clinical trial management systems (CTMS). Thus, it is possible to create clinical sites as business partners with site group assignment, pricing and condition type configuration. By this, the master data foundation enables the intuitive search of clinical manufacturing and distribution objects and processes based on clinical study parameters.  

At the same time, SAP Intelligent Clinical Supply Management also leverages commercial serialization models, such as SAP Advanced Track and Trace for Pharmaceuticals, and supports blinding needs and medication lists that are specific for clinical processes.  

Distribution from production to depot 

SAP Intelligent Clinical Supply Management contains a comprehensive set of features relevant for a smooth distribution from production to depot. Aside from standard features and apps, such as Display Stock Overview, Monitor Stock requirement list, Create Purchase Requisition via Purchase Requisition Assignment List, etc., several apps have been enhanced for the specific needs of organizing clinical trials. The following paragraphs will highlight some of them: 

With the app Analyze Stock at Depots (Figure 1), users can check packed clinical finished goods (CFGs) in inventory managed depots and can view more details of the respective handling units (HUs). Users with the appropriate permissions can also get more insights into medication numbers in an HU. To gain an even better overview, users can use visual filters to visualize the information and can also analyze data step-by-step from different perspectives.

Figure 1: Analyze Stock at Depots App

The Reconcile Stocks app has been specifically enhanced for SAP Intelligent Clinical Supply Management and is part of several business monitoring functionalities which have been created for the specific needs when conducting a clinical trial. It enables users to generate a reconciliation report for all clinical sites and warehouses involved in a trial to get an overview of the stock use at all clinical sites. It is possible to quickly check the inventory for discrepancies, filter for and find missing items, create returns for selected items and export all data to a spreadsheet.  

At the same time, a validation of clinical distribution conditions is performed automatically in the background, such as do-not-ship/do-not-transfer checks, single protocol checks, and required remaining shelf life for import. These automated shelf-life expiration validations and checks help customers to reduce waste of CFGs in picking and distribution. 

The Manage Outbound Deliveries app was enhanced with clinical trial specific features, such as information about included medication numbers on item level and document recording in the Display Medication Kit app. Users can click on each delivery to see its details, such as its weight and volume. Depending on the current goods issue status, users can post a goods issue for a delivery. 

The inbound delivery is triggered automatically from outbound delivery via a dedicated output type at header level. To optimally meet the requirements during a clinical trial, the Manage Outbound Deliveries app is enhanced by the possibility to provide several clinical parameters: Study ID, Protocol ID, Medication Kit.  

Distribution from depot to clinical sites 

SAP Intelligent Clinical Supply Management contains all features being relevant for both intra-network distribution and clinical site shipments (picking, packing, repacking, kit destruction and returns management), enabling the processes around clinical-site shipments of medication kits and clinical site storage and operations.  

To easily create an order for non-IRT studies (IRT = Interactive Response Technology), a dedicated app Create Sales Order (Clinical Trials) was introduced and enhanced with the possibility to also enter medication numbers. In addition, the standard process Manage Outbound Delivery was enhanced to provide information about included medication numbers on item level, and to enable the document recording in the Display Medication Kits app.  

A central feature of the SAP Intelligent Clinical Supply Management Distribution module is the app “Display Medication Kits” (Figure 2). This dedicated app provides a good overview of all documents and goods movements a specific kit was touched by. It shows the status of the kit e.g. “Available” or “In Transit”, and the stock type e.g. “Unrestricted Use”. Thus, sales and distribution roles have full transparency on the kits throughout the distribution process. With this app, users can also check a kit’s current location. By this, it is possible to also track the delivery of a medication kit and its return based on clinical trial parameters. This app therefore closes the gap of existing solutions and provides an overall view of the lifecycle of the medication kit.  

Figure 2: View of a single Medication Kit within the Medication Display Medication Kit app

By the integration with SAP Global Trade Services, Clinical Operations Managers are also facilitated to comply with global cross-border regulations.

Integration with other systems

Distribution is a process involving the orchestration of information from many different systems. In modern digital supply chain solutions this information is directly exchanged via digital interfaces. For these reasons, SAP Intelligent Clinical Supply Management has been designed such that digital interfaces compliant with modern industry standards are an integral part of the distribution module.

Integration with Interactive Response Systems using GS1 standards

Interactive response systems (IRT) are widely used at sponsors and clinical sites to manage the patient and supply chain logistics and to eliminate the need for manual interventions. At clinical sites, these systems are used to call for shipments of supplies to sites and to also trigger automatic shipments from depots to sites. Therefore, SAP Intelligent Clinical Supply Management offers several APIs out of the box to streamline integration within the distribution network (Figure 3). Using the Shipment Request API, an IRT system can send a shipment request, automatically creating a clinical supply-specific sales order in SAP Intelligent Clinical Supply Management. During the follow-up process (picking of kits, creation of outbound deliveries, […], dispensation to the patient), the API package contains several interfaces to update inventory between SAP Intelligent Clinical Supply Management and the IRT provider, guaranteeing continuous site stock visibility.

For optimal integration to external systems, these APIs are compliant to GS1 industry standards wherever possible. GS1 standards in healthcare such as GTINs and GLNs are global, technology-independent standards allowing global interoperability and compatibility for identification and data exchange. Whereas they are long-established in commercial supply chains they are now rapidly adopted for clinical supply chains by sponsors and vendors, thus creating a demand from many customers for GS1 compatible software solutions.

Figure 3: Overview of available interfaces for IRT integration. SAP Intelligent Clinical Supply Management offers the possibility of IRT integration at different phases of the study. Interfaces for retrieving information about study data, actual enrollment, drop-offs and visit confirmation are shown in red (see planning and forecast module). Interfaces concerning distribution processes (shipment requests, information about shipment statuses, dispatching and dispensing statues and kit status changes) are indicated in green and blue.

3PL Integration

The complexity of clinical trials and the resultant complexity of clinical distribution (cold chain solutions, just-in-time shipment, global shipments) also necessitates the commissioning of third-party logistics service providers (3PL). The 3PLs are external vendors who are responsible for the warehousing and distribution activities of clinical supplies that are performed at their own locations and using their own systems. In this context, they will receive inbound shipment of clinical supplies, they will store the clinical supplies and they will ship the clinical supplies according to outbound shipment requests. The SAP Intelligent Clinical Supply Management distribution module also takes these requirements into account and uses industry best practices for 3PL integration to provide real-time information on inventory levels, replenishments, shipments, returns and stock adjustments.

To enable the end-to-end supply chain visibility, individual 3PL locations can be defined in SAP S/4 HANA as plants or storage locations and associated material requirement planning areas. By this, essential information such as receipt advice, receipt confirmation, shipment request, shipment confirmation, stock updates, and stock reporting can be easily exchanged between the two systems (Figure 4).

Figure 4: Available interface for integration of 3rd Party Logistics

Grouping of distribution relevant apps 

For the best user experience, all clinically relevant enhancements and all new developments for the distribution process can be grouped together if desired (Figure 5). By using the “spaces” feature, all apps related to distribution activities are collected in one single tab, even sorted according to business user needs. Thus, clinical operators only need to access a single system to address the different processing steps during a clinical trial.

Figure 5: Overview of the Distribution Module of SAP Intelligent Clinical Supply Management. The solution is based on the human-centered design system SAP Fiori. Similar to what is shown here, other modules of SAP Intelligent Clinical Supply Management can be also displayed sorted according to business needs.

Conclusion 

The distribution module of SAP Intelligent Clinical Supply Management completes the end-to-end process of accomplishing a cost-effective and well-executed clinical trial. It leverages existing standard applications and components of SAP S/4HANA that are used in commercial processes providing specifically tailored enhancements targeting the needs of clinical trials. Its connections to IRT and 3rd party logistics supersede failure-prone manual information exchange and communication. Thus, it adds the final touch needed for the execution of end-to-end process operations to plan, source, manufacture, distribute, and reconcile supplies for clinical research and development. 

Distribution module at a glance 

The SAP Intelligent Clinical Supply Management Distribution module is part of an SAP S/4HANA add-on covering the following functionalities:  

• Supporting distribution from production to depot as well as from depot to the clinical site while guaranteeing a continuous site stock visibility 
• Dispensing information, kit destruction tracking and returns management 
• Do not ship, do not transport checks in sales, delivery and for Stock Transfer Orders (STOs)
• Expiry lead time validation 
• Kit tracking (via SAP Advanced Track and Trace for Pharmaceuticals) 
• GS1 standards support 
• Interfaces to other external systems:
  • IRT integration
  • 3PL integration 

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This article is the last part of a five-part blog series on SAP Intelligent Clinical Supply Management. The previous articles were already published some weeks ago. Please be invited to follow the tag “SAP Intelligent Clinical Supply Management” to not miss any of the future articles posted on this topic. We are also happy to receive your feedback, questions or thoughts in a comment.