The image illustrates the various features offered by SAP Intelligent Clinical Supply Management.
Study Management (Study Master; SAP Business Technology Platform Component)
- Setup of study master data including completion checks and guided review.
- Support for blinded and unblinded studies and various study types, such as titration, dose escalation, adaptive studies, and platform trials.
- Modeling of complex treatment schedules, with graphical visualization.
- Automatic calculation of required site seeding demand based on-site information.
Planning and Forecasting (Demand Forecasting; SAP Business Technology Platform Component)
- Rough demand forecasting for early demand planning on drug substance or drug product level.
- Deterministic demand planning - calculation and scheduling of demand including support for subject switching and dropouts.
- Thresholds, alerts, and automatic re-planning.
- Supply pooling across studies
- Interfaces for Interactive Response Technology (IRT) integration.
Manufacturing and Packaging (Make; SAP S/4HANA Add-On)
- Treatment-specific blinding and clinical serialization of treatment kits.
- Country/region-specific shelf life management and extension functionality.
- Support for shelf-life extensions and relabeling at sites through depots.
- System-supported batch allocation and expiry date calculation.
- Support clinical batch release through integration with SAP Batch Release Hub for Life Sciences.
- Master data monitor to check readiness for packaging.
- Clinical trial-specific enhancements for in-house GS1-compliant labeling.
- Integration with contract manufacturing organizations via purchase orders.
- Handling of regulatory information, including shelf lives:
- Support for flavors.
- Interface to receive information from regulatory information management (RIM) systems.
- Regulatory alerts and push notifications to planners.
- Medication number lists:
- Optional generation of medication numbers via SAP Advanced Track and Trace for Pharmaceuticals.
- Approval of medication number lists.
- Generation of mock lists.
- Central app and repository for molecule-based descriptions.
- Support for rework orders.
- Costing: Support for work breakdown structure (WBS) elements in purchase orders.
Quality Management (SAP Batch Release Hub for Life Sciences; SAP S/4HANA Add-On)
- SAP Batch Release Hub for Life Sciences can be used for the batch release process.
- The use of SAP Batch Release Hub for Life Sciences is optional.
Note
For more detailed insights about the SAP Batch Release Hub for Life Sciences, refer to SAP Batch Release Hub for Life Sciences.Distribution and Dispensing (Deliver; SAP S/4HANA Add-Ons)
- Distribution of clinical finished goods (open label and serialized with medication kits) between depots and to clinical sites (domestic and cross-border), participating in a study.
- Validation of orders between depots and from clinical sites in accordance with regulatory rules and clinical trial compliance checks.
- Assignment of batches to stock transport orders in accordance with regulatory rules and clinical trial compliance checks.
- Integration of third-party logistics providers based on medication kits.
- Shelf-life extensions with subcontracting purchase order scenarios.
- End-to-end traceability of medication kits based on SAP Advanced Track and Trace for Pharmaceuticals.
- Visibility into inventory levels at clinical sites.
- Supply chain activities such as dispensing, scrapping, and returns handling of medication kits.
- External APIs for IRT providers promote the application of GS1 standards to clinical trials.
Product Components
The image shows the product components of SAP Intelligent Clinical Supply Management, the interfaces between these components, and the third-party integration options.
Integration between SAP Business Technology Platform and SAP S/4HANA
SAP Intelligent Clinical Supply Management is a hybrid solution, meaning it has cloud components on the SAP Business Technology Platform (SAP BTP) as well as SAP S/4HANA components that need to communicate with each other.
The following communication-channels are used:
- Cloud Connector: The Cloud Connector is especially important for the communication direction Cloud to S/4HANA and creates a secure tunnel to the SAP S/4HANA system.
- SAP Event Mesh: SAP Event Mesh plays a significant role in synchronizing data between the cloud-based option for planning and the SAP S/4HANA-based option for operations. Events can also be used as a trigger for individual follow-up actions.
- oData APIs: oData APIs also play a significant role when it comes to the exchange of data between the cloud and SAP S/4HANA. For example, APIs can be called to receive study information from the cloud environment.
Note
For more detailed insights about the configuration of the Cloud Connector as well as SAP Event Mesh, refer to the Administration Guide for SAP Intelligent Clinical Supply Management.Integration Between SAP Intelligent Clinical Supply Management and Clinical Supplies Network (Third-Party Systems)
SAP Intelligent Clinical Supply Management also provides public endpoints (events and oData APIs) to support various integration scenarios.
The following chapters give an overview of the available APIs and events that support the integration of third-party systems, as well as the integration between SAP Intelligent Clinical Supply Management BTP and SAP Intelligent Clinical Supply Management S/4HANA.
Events Overview
The table shows the events available for the SAP Intelligent Clinical Supply Management.
Events
| Topic | Sub-Topic | CRUD Scenarios | Fields | Technical Topic Name |
|---|---|---|---|---|
| Study | General | Create, Change, Delete | Study-ID | /study |
| Study | Status change | Change | Status | /study/status |
| Study | Material requested | Can be triggered on creation of a request for a new material | no change | /study/material |
| Configuration | Study type | Create, Change, Delete | Description | /config/studyType |
| Configuration | Study phase | Create, Change, Delete | Description | /config/studyPhase |
| Configuration | Therapeutic area | Create, Change, Delete | Description | /config/therapeuticArea |
| Configuration | Study status | Create, Change, Delete | Kit ID generation, Distribution flags, and so on, Description | /config/status |
| Configuration | Workflow Setting | Change | Enable Material Requests, Trigger E-Mail Notifications, Default Recipients, Default Recipient Roles, Event Trigger for Material Requests | /config/workflowSetting |
| Configuration | General Setting | Change | S/4 API Version, DMS Repository, Enable Repository Descriptions, Placeholder Distributing Depot, Placeholder Site Group | /config/generalSetting |
| Configuration | Demand Category | Create, Change, Delete | Description | /config/demandCategory |
| Configuration | Enrollment Curve | Create, Change, Delete | Enrollment Curve Name, Enrollment Curve Description | /config/enrollmentCurve |
| Configuration | Contact Role | Create, Change, Delete | Contact Role Name | /config/contactRole |
| Configuration | Lead Molecule | Create, Change, Delete | Description, External ID, Source System | /config/leadMolecule |
| Configuration | External Identifier | Create, Change, Delete | External Identifier Name, Visible by Default | /config/externalIdentifier |
| Configuration | Monitoring Threshold | Create, Change, Delete | Comparison, Alert Threshold | /config/monitoringThreshold |
| Configuration | Recalculation Schedule | Create, Change, Delete | Description, Days of Week, Time | /config/recalculationSchedule |
| Configuration | IRT Notifications Settings Change | Create, Change, Delete | ID, Notification Type | /config/notifications/irt |
| Configuration | RIMS Notifications Settings Change | Create, Change, Delete | ID, Notification Type, Active, Trigger Type, list of emails | /config/notifications/rims |
API Overview - SAP Business Technology Platform
The table shows the APIs available for the SAP Intelligent Clinical Supply Management Business Technology Platform.
API Overview
| Interface | Description | Stream | Environment | Category |
|---|---|---|---|---|
| Study Data | Allows to create Study Data | SM | Cloud | Inbound |
| Study Configuration Data | Allows to create Study Configuration Data | SM | Cloud | Inbound |
| Study Data | Generic API to provide all the related study and scenario settings | SM | Cloud | Outbound |
| CTMS - Study Data | This API is used to receive study data from an external clinical trial management system (CTMS) | SM | Cloud | Inbound |
| Lead Molecule | This API is used to receive project information from an external system in order to configure projects | SM | Cloud | Inbound |
| IRT - Study Master Data and Actual Enrollment Data | This API is used to receive master data (Subject Status, Treatment Arm, Dose, Phase) and actual enrollment data (on visit level) from an IRT system | DF | Cloud | Inbound |
| Scheduling Agreement | This enhancement of an SAP S/4HANA standard API is used to retrieve scheduling agreements with CTSM-specific information | DF | SAP S/4HANA | Outbound |
| MRP relevant Demands | SAP Intelligent Clinical Supply Management-specific API to expose MRP relevant netted (reduced by consumption) demands from the scheduling agreements. Including demands that stem from the delivery orders (triggered by the consumption). | DF | SAP S/4HANA | Outbound |
| External Recalculated Enrollment | Allows to provide external enrollment | DF | Cloud | Inbound |
| Demand Forecast API | Allows to retrieve demand forecast figures | DF | Cloud | Outbound |
API Overview – SAP S/4HANA (Make)
The table shows the APIs available for SAP Intelligent Clinical Supply Management S/4HANA (Make).
API Overview – SAP S/4HANA (Make)
| Interface | Description | Stream | Environment | Category |
|---|---|---|---|---|
| Process Order | API_PROCESS_ORDER_2_SRV Enhancement of standard Process Order API with SAP Intelligent Clinical Supply Management-specific data like PCN, Expiry Date, and Med No. The API is used for integrating CMOs but also to connect to external label printing solutions. | Make | SAP S/4HANA | Outbound |
| Process Order Confirmation | API_PROC_ORDER_CONFIRMATION_2_SRV Allows assignment of MedKit to the new batch in the GR functionality. | Make | SAP S/4HANA | Inbound |
| Purchase Order | API_PURCHASEORDER_PROCESS_SRV The API is used for integrating CMOs. | Make | SAP S/4HANA | Outbound |
| Purchase Order Confirmation | /CTCO/API_PURCH_ORDER_CONF Confirm PO and do GR and generate medication kits. Same functionality as for process orders. | Make | SAP S/4HANA | Inbound |
| Batch Master | API_BATCH_SRV Enhancement of standard Batch Master API with SAP Intelligent Clinical Supply Management-specific fields. | Make | SAP S/4HANA | Outbound |
| RIMS Interface | /CTCO/API_SHELF_LIFE_RIMS Allows provision of shelf-life information from an external RIMS. | Make | SAP S/4HANA | Inbound |
API Overview – SAP S/4HANA (Deliver)
The table shows the APIs available for SAP Intelligent Clinical Supply Management S/4HANA (Deliver).
API Overview – SAP S/4HANA (Deliver)
| Interface | Description | Stream | Environment | Category |
|---|---|---|---|---|
| SAP Intelligent Clinical Supply Management - Site Master | Standard Business Partner API with SAP Intelligent Clinical Supply Management-specific enhancements to create/import Site Business Partners (for example, from CTM system) | Deliver | SAP S/4HANA | Inbound |
| IRT - Released Inventory | The Inventory Report is used to communicate current levels of inventory of items within a given location. Providing information about where inventory "is" at any point in time. SAP Intelligent Clinical Supply Management-own API with the structure of the API_MATERIAL_STOCK and additionally enhanced by the GS1 industry-specific fields. | Deliver | SAP S/4HANA | Outbound |
| IRT - Shipment Request (Delivery Order) | The IRT systems send a shipment request, which resolves in an SAP Intelligent Clinical Supply Management-specific Sales Order (= delivery order) in SAP S/4HANA. The API is a new SAP Intelligent Clinical Supply Management-specific OData (V2) service with the interface signature as API_SALES_ORDER (https://api.sap.com/api/OP_API_SALES_ORDER_SRV_0001/resource), including the GS1 industry-specific fields (POST). | Deliver | SAP S/4HANA | Inbound |
| IRT - Shipment Confirmation | The Shipment Confirmation informs the clinical site that the delivery order has been created in SAP Intelligent Clinical Supply Management. The API is a new SAP Intelligent Clinical Supply Management-specific OData (V2) service with the interface signature as API_SALES_ORDER (https://api.sap.com/api/OP_API_SALES_ORDER_SRV_0001/resource), including the GS1 industry-specific fields (GET). | Deliver | SAP S/4HANA | Outbound |
| IRT – Dispatch Advice (Advanced Shipping Notification - ASN) | The Dispatch Advice corresponds in SAP to the Advanced Shipping Notification. This advice is used to inform the site that they will receive the logistics units they ordered. The OData standard service for Outbound Delivery (https://api.sap.com/api/OP_API_OUTBOUND_DELIVERY_SRV_0002/resource) has been enhanced with new entities relevant for clinical trials (GS1 fields). | Deliver | SAP S/4HANA | Outbound |
| IRT – Receiving Advice | The purpose of this IRT message is to notify SAP Intelligent Clinical Supply Management that the goods were received and add the stock to the site inventory. The Receiving Advice contains the Delivery Document Number of the SAP Intelligent Clinical Supply Management Inbound Delivery. The API is a new OData interface with fields of the standard standard (https://api.sap.com/api/OP_API_INBOUND_DELIVERY_SRV_0002/resource) enhanced by the GS1 industry´specific fields. | Deliver | SAP S/4HANA | Inbound |
| IRT - Dispensing Advice | The dispensation leads to a reduction of the site stock and therefore a goods issue material movement is created to adapt the site stock in SAP Intelligent Clinical Supply Management accordingly. The inbound ODATA Service "Material Document" (API_MATERIAL_DOCUMENT) enhanced by GS1 industry-specific fields, is used to trigger a Material Document posting for the related CFG stock. | Deliver | SAP S/4HANA | Inbound |
| IRT – Kit Status Change | The Kit Status Change could lead to a reduction of the site stock and therefore a goods issue material movement is created to adapt the site stock in SAP Intelligent Clinical Supply Management accordingly. The inbound ODATA Service "Material Document" (API_MATERIAL_DOCUMENT) enhanced by GS1 industry-specific fields, is used to trigger a Material Document posting for the related CFG stock. | Deliver | SAP S/4HANA | Inbound |
LE-IDW Inbound- and Outbound Delivery | Integration of inbound and outbound deliveries with the systems of the 3PL location (Setup of LE-IDW) | Deliver | SAP S/4HANA | Inbound and Outbound (IDOC) |
| Master Data Decentral EWM | Products, Business Partners and Batches master data essential for warehouse processes are primarily maintained in the central SAP S/4HANA component, and therefore must be distributed to the SAP S/4HANA decentral EWM system. | Deliver | SAP S/4HANA | Outbound (IDOC ALE) |
Authentication Scenarios Supported by SAP Intelligent Clinical Supply Management
The image shows the different authentication scenarios supported by SAP Intelligent Clinical Supply Management.
SAP Intelligent Clinical Supply Management Authentication via Identity Authentication Service
This scenario describes the way of authentication against the SAP Intelligent Clinical Supply Management Cloud via the Identity Authentication service.
To use this scenario, it is best practice to connect the corporate identity provider (for example, Azure Active Directory).
For authentication, the Identity Authentication service redirects the authentication request to the corporate identity provider, who then authenticates the user, responds to the service, which then finally authenticates the user against the SAP Intelligent Clinical Supply Management Cloud.
SAP S/4HANA Authentication via Cloud Connector
This scenario describes the way of authentication against the SAP Intelligent Clinical Supply Management SAP S/4HANA via the Cloud Connector.
In order to create a secure channel to the SAP Intelligent Clinical Supply Management SAP S/4HANA (which usually stands behind a firewall), the Cloud Connector can be used by the SAP Intelligent Clinical Supply Management Cloud to read, create, or change data in SAP Intelligent Clinical Supply Management SAP S/4HANA.
The authentication is possible via a technical user or principal propagation but it is highly recommended to use principal propagation.
SAP Intelligent Clinical Supply Management Cloud Authentication via OAuth 2.0 Client Credentials Flow
The authentication via the OAuth 2.0 Client Credentials Flow is needed to use the external APIs (for example, by an IRT).
Credentials (with technical users) can be generated using the OAuth 2.0 protocol, which then can be used to call external APIs.
To call SAP Intelligent Clinical Supply Management Cloud APIs, this flow can also be used from SAP Intelligent Clinical Supply Management SAP S/4HANA.
Note
Check out these extra links if you're interested in learning more or deepening your understanding. They're packed with further information to enrich your knowledge.