Building Intelligent Clinical Supply Management With SAP S/4HANA and SAP BTP

LeverX helped develop a solution to automate and improve the clinical supplies process and gain better visibility into the status of clinical supplies worldwide.

Client

Our client is a multinational healthcare company operating globally through two divisions: Pharmaceuticals and Diagnostics.

Challenge

The client lacked sufficient visibility into clinical supplies, which affected the agility of clinical trials. The company also needed more accurate planning and inventory management across its clinical supply operations.

Solution

SAP Intelligent Clinical Supply Management (ICSM) combines cloud-based study management and planning functionality with SAP S/4HANA-based manufacturing and distribution processes. The solution is structured around four functional areas: Study Master, Planning & Forecasting, Manufacturing, and Distribution.

The original project scope specifically details LeverX's work in the following areas:

• Planning & Forecasting: supports demand forecasting and deterministic planning, manual adjustments, scenario simulations and comparisons, thresholds and alerts, automatic replanning, and supply pooling across studies. The functionality also integrates with interactive response technology (IRT) and SAP supply planning tools.
• Manufacturing: Supports treatment-specific blinding and clinical serialization, country-specific shelf-life management, batch allocation, expiry date calculation, and readiness checks for packaging. The solution also includes enhancements for in-house GS1-compliant labeling and integration with contract manufacturing organizations (CMOs).
• Distribution: Supports distribution between depots and clinical sites, site stock visibility, dispensing information, kit destruction tracking, returns management, expiry lead-time validation, cold chain management, and GS1 standards. Integration with third-party logistics providers (3PLs) and IRT systems connects distribution activities with the wider clinical supply process.

Technology Stack

The solution uses the following SAP and development technologies across its planning, operations, integration, data, and application layers.

• Clinical supply management solution: SAP Intelligent Clinical Supply Management (ICSM)
  Supports study setup, planning, manufacturing, and distribution processes across the clinical supply chain.
• ERP and operations layer: SAP S/4HANA, add-on for Life Sciences
  Supports manufacturing and distribution processes for clinical supplies, including batch management, shelf-life controls, labeling, and logistics operations.
• Cloud platform and application development: SAP Business Technology Platform (SAP BTP) / SAP Cloud Application Programming Model (CAP)
  Supports cloud-based study management and planning functionality as well as the development of application services and extensions.
• Event-driven integration: SAP Event Mesh
  Supports event-based data synchronization between cloud-based planning and SAP S/4HANA-based operations.
• Database: SAP HANA
  Provides database services for storing and processing application data used by the solution.
• User interface: SAP Fiori elements / SAPUI5
  Support user-facing applications for accessing study management, planning, and clinical supply functionality.
• Application runtime and language: Node.js / JavaScript
  Support the development of cloud application logic and services used within the solution.

Results

With SAP Intelligent Clinical Supply Management, our customer could achieve the following results:

• Up to 50% lower implementation costs
• 10-15% shorter lead times
• 30-40% lower running costs
• 30-40% reduction in excess inventory
• Up to 10% shorter clinical trial cycles