A GxP-validated S/4HANA Private Cloud implementation for a global rare disease leader — streamlining clinical supply chain operations, ensuring regulatory compliance, and enabling scalable growth.
CLIENT
PTC Therapeutics is a patient-centered biopharmaceutical company dedicated to discovering, developing, and commercializing medicine for rare and severe diseases with novel small molecule and gene therapies. Founded in 1998, PTC pioneered rare disease treatments, leveraging strong scientific and clinical expertise, a global infrastructure, and a business footprint across 50 countries.
CHALLENGE
A complex and highly regulated clinical supply chain hindered expansion to full-scale operations
PTC Therapeutics faced significant challenges as it expanded from clinical trials to full-scale commercial operations. Its enterprise resource planning (ERP) system could not manage PTC’s complex and highly regulated internal manufacturing, multi-tiered subcontractors, and clinical supply chain spanning over 35 countries with many legal entities and detailed transactions. The existing public cloud solution required costly, frequent testing and validation of upgrades to sustain FDA and GxP compliance (Good x Practice).
Additionally, PTC needed to connect its supply chain with its financial model to streamline operations, improve data accuracy, and enhance decision-making. Operating on two separate ERP systems and using manual spreadsheets led to inefficiencies, data discrepancies, and increased risk of errors.
TRANSFORMATION
Streamlining clinical trial supply chain with SAP private cloud ERP for rare diseases
The decision to adopt the SAP S/4HANA Cloud Private Edition for ERP (enterprise resource planning) was driven by the need for a robust, scalable system capable of handling PTC’s intricate operations and stringent regulatory requirements. UST analyzed various ERP solutions and recommended SAP S/4HANA Cloud Private Edition which would allow PTC to create a robust, scalable system capable of handling the firms intricate operations and stringent regulatory requirements.
UST leveraged SAP Activate methodology to plan and execute the installation of the S/4HANA single-tenant private cloud ERP system. This Agile, iterative approach involves four phases: prepare, explore, realize, and deploy. UST on-boarded teams, defined roles, built and tested the system, and conducted a fit-to-standard analysis to validate the solution with minimal disruption. Additionally, the UST best practices template for ERP implementation, known to accelerate implementations by up to 70%, expedited planning and implementation by rapidly defining target business process flows and system configurations.
The new cloud ERP for rare diseases integrates and automates key business processes, including internal manufacturing, supply chain management, finance, and regulatory compliance. SAP Multi-Bank Connectivity automates many manual financial reconciliation tasks, significantly improving workflow speed and accuracy while reducing the workload on the supply chain team. SAP Ariba procurement software supports close collaboration with PTC’s suppliers, streamlining the buying and invoicing process across the organization. Interfacing with SAP’s business network facilitates real-time communication with Contract Manufacturing Organizations (CMOs) and subcontractors about essential information such as expiration and batch genealogy.
The new system gave PTC Therapeutics control over upgrade timing, regulatory compliance, and future growth, enabling better management of its complex operations and expanding business needs.
IMPACT
Streamlining clinical trial supply chain with SAP
Integrating the supply chain and financial models offers real-time visibility into financial impacts, better coordination, and more informed strategic planning, all of which are crucial for supporting PTC’s growth and complex global operations. The new SAP S/4HANA Cloud Private Edition for ERP, brought significant improvements to PTC Therapeutics in several key areas:
- Automated financial processes: SAP Multi-Bank Connectivity transformed many financial reconciliation tasks, such as currency conversion and transaction matching, significantly improving workflow speed and accuracy while reducing the supply chain team’s workload.
- Enhanced clinical supply chain management: Automation of previously manual processes ensures meticulous tracking of study protocols and timings, reducing error risks and improving supply chain planning, data management, and compliance.
- Improved supply chain collaboration: SAP Ariba procurement software facilitates close collaboration with PTC’s suppliers, streamlining the buying and invoicing process across the organization and enabling real-time communication with CMOs and subcontractors.
- Delivered holistic visibility across functions: The integrated system provides comprehensive visibility across manufacturing, supply chain, finance, and regulatory compliance, allowing for better coordination, improved data accuracy, and enhanced decision-making capabilities.
“UST provided platinum-level consultants with decades of SAP experience”
— Chris Famula, Head of Enterprise Applications and Data, PTC Therapeutics.
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