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SAP Intelligent Clinical Supply Management

Clinical supply chain planning and operations for clinical trials, from demand forecasting to manufacturing, packaging, and site-level distribution.

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Overview

SAP Intelligent Clinical Supply Management is a clinical supply chain management system designed for life sciences organizations. It supports the planning, manufacturing, packaging, labeling, and distribution of clinical trial materials, providing visibility into clinical supplies from initial planning through to patient delivery.

The solution integrates with clinical trial management systems (CTMS) and interactive response technology (IRT) to address blinding and randomization requirements for clinical trials. It is available in a hybrid deployment model, combining cloud-based planning modules with on-premise extensions for SAP S/4HANA for clinical study operations.

Key Benefits

  • Reduced cycle time and improved efficiency: Automated and simplified clinical trial supply chain processes help reduce complexity and lower costs.
  • Increased transparency: Site-level visibility supports clinical planning by incorporating actual enrollment and dispensing data into clinical supplies replenishment decisions.
  • Optimized collaboration: Supply management processes are integrated across all clinical supply stakeholders, including suppliers, manufacturers, third-party logistics providers (3PLs), and clinical sites.

Setup of Complex Clinical Studies

  • Maintain clinically relevant parameters for study configuration.
  • Define and manage complex study designs with built-in support for various study types.
  • Monitor calculation statuses of studies via a study overview page.
  • Integrate with any CTMS or clinical trial management software.

Planning and Forecasting

  • Begin demand planning at the drug substance or drug product level as soon as a use case is identified.
  • Perform deterministic calculations for demand planning.
  • Simulate multiple planning scenarios based on projected or actual subject enrollment figures and visit data.

Intelligent Manufacturing and Packaging

  • Manage medication lists for both open and blinded serialized trials.
  • Perform batch allocation and expiry date calculations.
  • Provide information to support internal packaging and external labeling processes.
  • Support shelf-life management for clinical trial materials.

Stock Visibility and Distribution

  • Enable stock visibility beyond the depot level, down to the specific site and kit ID level.
  • Support import compliance through picking, packing, and repackaging based on medication IDs for clinical kits.
  • Integrate with third-party logistics providers using GS1 industry-standard interfaces.

SAP Intelligent Clinical Supply Management supports hybrid deployment with both cloud and on-premise modules, and includes extensions for SAP S/4HANA. Implementation and ongoing support are available through SAP's consulting services, support plans, and the SAP Help Portal.

Meta

Domain
Clinical Trial Management
Subdomain
Randomization & Trial Supply Management
Software type(s)
Workflow Automation
Deployment type(s)
Hybrid
Industry vertical(s)
PharmaBiotechCRO
Development stage(s)
Clinical
Target user(s)
Research ScientistQA / Regulatory AffairsIT / Systems Admin / Data Engineer
Compliance standard(s)
GxP