Clinical Trial Supply Chain Management offering
This advanced solution addresses the specific blinding and randomization needs for clinical trials to facilitate demand forecasting, manufacturing, packaging, labelling, and shipments of clinical trial materials. Download the Documentwww.sap.com/legal-notice
72392enUS (24/08) © 2024 SAP SE or an SAP affiliate company. All rights reserved. See Legal Notice on
www.sap.com/legal-notice for use terms, disclaimers, disclosures, or restrictions related to this material.
SAP Intelligent Clinical Supply Management
Life sciences | Intelligent Clinical Supply Chain Management
The SAP Intelligent Clinical Supply Management solution is an industry cloud offering that leverages the power of SAP S/4HANA and SAP Business Technology Platform
(SAP BTP) to provide end-to-end processes and visibility for planning, sourcing, manufacturing, distribution, and reconciliation of drug substances in clinical R&D.
Overview
This advanced solution:
• Integrates with IRT's (Interactive Response Technology) and CTMS (Clinical Trial Management Systems) to address the
specific blinding and randomization needs for clinical trials to facilitate demand forecasting, manufacturing, packaging,
labeling, and shipment of clinical finished goods.
• Fosters more accurate planning for the life sciences industry by infusing clinical trial parameters as well as enrollment
rates into the supply and demand planning processes, through integration with any IRT.
• Strengthens your clinical supplies processes by supporting new types of clinical trials and medicine dispensations.
• Brings full visibility into your global supply status, involving all stakeholders in the supplies network for clinical trials, and
proactively preventing shortages or waste when enrollment is faster or slower than expected.
• Provides full transparency for working with contract manufacturing organizations (CMOs).
• Includes efficient stock transfer management, comprehensive packaging and labeling management, automated batch
allocation, and shelf-life management, allowing you to achieve greater efficiency and reduced costs.
Business processes and capabilities
SAP Intelligent Clinical Supply Management
can deliver:
• Higher flexibility for fulfilling future clinical
supplies business needs.
• Streamlined processes and valuable real-
time data that can help you make informed
decisions on every aspect of the supply chain.
• Improved planning by taking actual
enrollment and dispensing into account for
replenishment driven by IRT.
• End-to-end integration for study design,
demand forecasting, sourcing, manufacturing,
and distribution, enhancing supply chain
integrity at every step.
Industry consortium
For the design and development of Intelligent
Clinical Supply Management, SAP formed an industry
consortium to discuss the future needs of the life
sciences industry. We invite other companies to join
this discussion. Just contact an SAP representative.
Business value
• Streamline complex study management: Maintain clinically
relevant parameters, define and handle support for various study
types, and seamlessly integrate with any IRT's. Manage digital
approval processes required before and during a clinical trial.
• Plan and forecast in real-time: Carry out deterministic calculations
for demand planning and simulate multiple planning scenarios
based on projected or actual subject enrollment figures and visits.
Compare the plan to actual enrollment to improve planned
predictions of supplies demand and avoid shortages and waste.
• Ensure quality, efficiency, and compliance in manufacturing:
Manage medication lists for open and blinded serialized trials,
including performing batch allocation and expiry date calculations.
Provide information for internal packaging and external labeling
and ensure efficient shelf-life management and compliance with
good practice guidelines (GxP).
• Gain better stock visibility and more efficient distribution:
Drive visibility down to the specific site and kit ID. Incorporate
picking, packing, and repackaging processes and integrate
third-party logistics using the interfaces specified in the GS1
industry standard.
• Improve coordination with research and manufacturing
partners: Exchange and execute subcontracting purchase orders
for external production of clinical finished goods (CFGs).
Benefits
• Fast cycle times: Reduction in cycle times for the clinical trial
supply chain, supporting quick adaptation to change.
• Improved accuracy: Integrated processes to reduce errors
and delays, along with accurate planning to reduce inventory
excesses.
• Greater flexibility: Quick and flexible responses to future
trends and new types of clinical trials with more complex
designs, atop a scalable architecture that accommodates
multiple clinical supply models in one system.
• Optimized collaboration: Streamlined supply management
processes integrating all clinical supply stakeholders,
including suppliers, CMOs, third-party logistics managers
(3PLs), and clinical sites.
• Improved efficiency: Simplified and automated processes,
eliminating manual data entry, reducing complexity, and
providing system guidance.
• Increased transparency: Optimized site-level visibility and
improved clinical planning by taking actual enrollment and
dispensing into account for clinical supplies replenishment.
• Lower costs: Lower total cost of ownership through
leveraging existing SAP S/4HANA software running on SAP
BTP for faster implementation of new features.
• Enhanced regulatory compliance: Improved efficiency in
releasing batches for specific countries, and less time spent
on documentation.
Learn more
• Intelligent Clinical Supply Management on sap.com
• Benefits of Intelligent Clinical Supply Management
• Powering clinical supply innovations
• The SAP Cell and Gene Therapy Orchestration solution
• SAP Batch Release Hub for Life Sciences
72392enUS (24/08) © 2024 SAP SE or an SAP affiliate company. All rights reserved. See Legal Notice on
www.sap.com/legal-notice for use terms, disclaimers, disclosures, or restrictions related to this material.
SAP Intelligent Clinical Supply Management
Life sciences | Intelligent Clinical Supply Chain Management
The SAP Intelligent Clinical Supply Management solution is an industry cloud offering that leverages the power of SAP S/4HANA and SAP Business Technology Platform
(SAP BTP) to provide end-to-end processes and visibility for planning, sourcing, manufacturing, distribution, and reconciliation of drug substances in clinical R&D.
Overview
This advanced solution:
• Integrates with IRT's (Interactive Response Technology) and CTMS (Clinical Trial Management Systems) to address the
specific blinding and randomization needs for clinical trials to facilitate demand forecasting, manufacturing, packaging,
labeling, and shipment of clinical finished goods.
• Fosters more accurate planning for the life sciences industry by infusing clinical trial parameters as well as enrollment
rates into the supply and demand planning processes, through integration with any IRT.
• Strengthens your clinical supplies processes by supporting new types of clinical trials and medicine dispensations.
• Brings full visibility into your global supply status, involving all stakeholders in the supplies network for clinical trials, and
proactively preventing shortages or waste when enrollment is faster or slower than expected.
• Provides full transparency for working with contract manufacturing organizations (CMOs).
• Includes efficient stock transfer management, comprehensive packaging and labeling management, automated batch
allocation, and shelf-life management, allowing you to achieve greater efficiency and reduced costs.
Business processes and capabilities
SAP Intelligent Clinical Supply Management
can deliver:
• Higher flexibility for fulfilling future clinical
supplies business needs.
• Streamlined processes and valuable real-
time data that can help you make informed
decisions on every aspect of the supply chain.
• Improved planning by taking actual
enrollment and dispensing into account for
replenishment driven by IRT.
• End-to-end integration for study design,
demand forecasting, sourcing, manufacturing,
and distribution, enhancing supply chain
integrity at every step.
Industry consortium
For the design and development of Intelligent
Clinical Supply Management, SAP formed an industry
consortium to discuss the future needs of the life
sciences industry. We invite other companies to join
this discussion. Just contact an SAP representative.
Business value
• Streamline complex study management: Maintain clinically
relevant parameters, define and handle support for various study
types, and seamlessly integrate with any IRT's. Manage digital
approval processes required before and during a clinical trial.
• Plan and forecast in real-time: Carry out deterministic calculations
for demand planning and simulate multiple planning scenarios
based on projected or actual subject enrollment figures and visits.
Compare the plan to actual enrollment to improve planned
predictions of supplies demand and avoid shortages and waste.
• Ensure quality, efficiency, and compliance in manufacturing:
Manage medication lists for open and blinded serialized trials,
including performing batch allocation and expiry date calculations.
Provide information for internal packaging and external labeling
and ensure efficient shelf-life management and compliance with
good practice guidelines (GxP).
• Gain better stock visibility and more efficient distribution:
Drive visibility down to the specific site and kit ID. Incorporate
picking, packing, and repackaging processes and integrate
third-party logistics using the interfaces specified in the GS1
industry standard.
• Improve coordination with research and manufacturing
partners: Exchange and execute subcontracting purchase orders
for external production of clinical finished goods (CFGs).
Benefits
• Fast cycle times: Reduction in cycle times for the clinical trial
supply chain, supporting quick adaptation to change.
• Improved accuracy: Integrated processes to reduce errors
and delays, along with accurate planning to reduce inventory
excesses.
• Greater flexibility: Quick and flexible responses to future
trends and new types of clinical trials with more complex
designs, atop a scalable architecture that accommodates
multiple clinical supply models in one system.
• Optimized collaboration: Streamlined supply management
processes integrating all clinical supply stakeholders,
including suppliers, CMOs, third-party logistics managers
(3PLs), and clinical sites.
• Improved efficiency: Simplified and automated processes,
eliminating manual data entry, reducing complexity, and
providing system guidance.
• Increased transparency: Optimized site-level visibility and
improved clinical planning by taking actual enrollment and
dispensing into account for clinical supplies replenishment.
• Lower costs: Lower total cost of ownership through
leveraging existing SAP S/4HANA software running on SAP
BTP for faster implementation of new features.
• Enhanced regulatory compliance: Improved efficiency in
releasing batches for specific countries, and less time spent
on documentation.
Learn more
• Intelligent Clinical Supply Management on sap.com
• Benefits of Intelligent Clinical Supply Management
• Powering clinical supply innovations
• The SAP Cell and Gene Therapy Orchestration solution
• SAP Batch Release Hub for Life Sciences