The following SAP IPE Life Science Products are Software as a Service (SaaS) solution hosted on SAP Business Technology Platform.

• Cell and Gene Therapy Orchestration (CGTO)

• Intelligent Clinical Supply Management (ICSM)

SAP Cell and Gene Therapy Orchestration (CGTO) solution helps life sciences companies organize, plan, and execute cell and gene therapy treatments. It covers the orchestration and integrity of the personalized therapy lifecycle and helps ensure that the right patients get the right treatments without errors. CGTO provides the ability to record and track the end-to-end integrity and traceability of the chain of identity (COI) and chain of custody (COC) of custom medicinal products and orchestrate their supply chain to ensure the product is delivered on-time.

 

SAP Intelligent Clinical Supply Management leverages the power of SAP S/4HANA software together with the SAP Business Technology Platform (BTP) to automate and improve the clinical trial supply process and enhance visibility into the status of clinical supplies worldwide. This advanced solution addresses the blinding and randomization needs of clinical trials and facilitates demand forecasting and the manufacturing, packaging, labelling, and distribution of clinical finished products.

 

CGTO and ICSM are built on SAP BTP - Cloud Foundry platform. It leverages SAP BTP services and is hosted on SAP BTP in the Europe Frankfurt (EU10) region.

 

SOC 1 reports are prepared in accordance with AT-C section 320, Reporting on an Examination of Controls at a Service Organization Relevant to User Entities’ Internal Control Over Financial Reporting, under Statement on Standards for Attestation Engagements (SSAE) No. 18, Attestation Standards: Clarification and Recodification. SOC 1 reports are specifically intended to meet the needs of the entities that use service organizations (user entities) and the CPAs that audit the user entities’ financial statements (user auditors).  Please note that this examination's scope does not include the controls and related control objectives of any subservice organizations. SOC 1 Type 1 report on the fairness of the presentation of management’s description of the service organization’s system and the suitability of the design of controls to achieve the related control objectives as of a specified date, whereas a SOC 1 Type 2 also includes the operating effectiveness of controls to achieve the related control objectives throughout a specified period.

 

SAP Cell and Gene Therapy Orchestration has prepared SOC 1 Type 2 audit reports by an independent 3rd party accountant. This version of the report covers the audit period 1. October 2023 to 31. March 2024.

 

The use of these reports is restricted to the management of the service organization, user entities, and user auditors. A copy of this report is available for all SAP Cell and Gene Therapy Orchestration customers who had productive and had financially-relevant systems during the audit period covered by the report.