SAP Intelligent Clinical Supply Management (SAP ICSM) is an advanced solution for clinical trials to facilitate study management, demand forecasting, manufacturing, packaging, labeling, and shipments of clinical trial materials.
Today, we are excited to share the highlights of Release 2605 for SAP Intelligent Clinical Supply Management. This release brings significant enhancements across planning, study management, compliance, user experience, and manufacturing, all designed to help clinical supply teams work faster, smarter, and with greater confidence.
Read on for the key highlights across all areas.
Compare Multiple Placeholder Study Scenarios
Program managers can now compare up to three scenarios of a placeholder study side-by-side directly in the Manage Programs app. The new compare menu on the forecast toolbar enables parallel analysis of demand forecasting results and planning figures, supporting faster, evidence-based decisions.
Enhanced Combination Therapy Modeling
Users can now choose to define treatment duration, visit frequency, and start offset at the material level within placeholder study scenarios. This makes it possible to accurately model complex combination therapy regimens (including staggered start/end times and varying visit schedules) directly during early program planning, long before detailed supply forecasting begins.
Smarter Study Search:
The Manage Studies app now lets you filter studies by specific study settings, such as study category, kit type specific depots, automatic side seeding, and demand recalculation schedule. Combined with variant management and the adapt filters option, you can save and reuse your preferred filter combinations. Finding the right study now takes seconds instead of minutes.
No More Gaps in Technical IDs:
When study entities such as kit types, blinding groups, or treatment groups are deleted, the system now automatically reuses the freed-up technical IDs, starting with the lowest available number. This eliminates unexplained numbering gaps and makes audit trails and compliance documentation significantly cleaner.
Copy Kit Type Design Including Component Identifiers
When reusing an existing kit type design (KTD) for a new study, users can now choose whether to copy component identifiers (CIDs) along with it, and if so, whether to include the existing responses or copy the structure only. If you choose not to carry over the original CIDs, the system still ensures that any identifiers marked as mandatory or default-visible in your configuration are added automatically to the new design. This eliminates a common source of manual errors and missed identifiers during study setup, saving time and giving teams greater confidence when building on existing kit designs.
Visualize Material Code Status in Study Master
Knowing the current status of a material (e.g. whether it is active for use, blocked for procurement, being phased out, or marked as obsolete) is essential for compliant and informed supply planning. Release 2605 introduces the cross-plant material status as a new column in the kit type table at both label group and site group levels within the Manage Studies app, and also makes it available in the Material Overview section. The status is fetched in real time from the SAP S/4HANA material master (MARA) and can additionally be included as a selectable value in approval item templates. This gives clinical and supply chain teams immediate visibility into material lifecycle status, reducing the risk of compliance issues and supporting better material selection decisions throughout the study.
Enhanced Material Request Information in Workflow Inbox
When trial managers and workflow recipients handle manual material requests, having the right context is critical for fast and accurate decisions. In release 2605, the workflow inbox now displays a significantly richer set of details for each request, including study description, study status, therapeutic area, lead molecule, packaging site, temporary material code, repository description, and the active countries for the assigned label group. Contacts are presented in a sortable table view, and country lists open in a clean popover showing only active entries. This improvement applies to manual material requests and reduces back-and-forth communication by putting all relevant study, kit, and material parameters directly in front of the person handling the request.
Kit Type Comments
Each kit type can now carry its own free-text comment (up to 500 characters), visible directly in the app, in approval items, and tracked in the Change Log app. This improves transparency and communication during study setup, and any post-approval changes trigger deviation management automatically.
Dynamic Visit Recalculation Based on IRT Actuals
A new optional feature allows future patient visits to be automatically rescheduled whenever IRT (Interactive Response Technology system) actual visit dates are received. All subsequent visits are recalculated from the latest real visit, not the original plan. This is especially critical for make-to-order protocols such as radioligand therapy, where timing between visits directly affects supply preparation.
Comprehensive Audit-Ready Export
The View Change History app (formerly named Export Change History) has been significantly enhanced. You can now export the full system change history, including configuration changes, to well-formatted Excel files suitable for internal and external audit requirements. Multi-object export (up to 20 objects at once, each on its own tab) and attribute-level detail are now supported. A dedicated export authorization role ensures only designated users can perform exports.
Approval of Country Lists for Booklet Materials with 4-Eye Check
Additions and deletions to country lists for booklet materials now require approval, with full support for a configurable 4-eye principle check. The Manage Country Lists for Booklets app displays approval status at both country and list level, all status changes are logged, and a warning is shown in the Clinical Supply Orders app if unapproved country list changes exist for a label group. When a user uploads a spreadsheet, the system adds only new countries rather than replacing the entire existing list. This ensures that booklet country assignments always go through a controlled, auditable review process – reducing the risk of compliance gaps and incorrect label distribution to unauthorized markets.
Block Medication Kits for Destruction
The Withdraw Batches app now supports blocking medication kits, completely or partially, for the purpose of destruction. The stock type of the affected batch is set to Blocked, preventing these kits from being considered in MRP planning. Depending on configuration, the system either posts the goods movement directly or creates a delivery document for SAP EWM and 3PL locations. An automation report (/CTCO/WITHDRAW_BATCHES) is also available for scheduled execution. This gives supply and quality teams a fast, controlled, and fully traceable mechanism to remove expired or unusable kits from the supply chain without relying on manual workarounds.
Inner Label Printing During Shelf-Life Revision
In response to new EU regulatory requirements for expiry dates on inner labels, it is now possible to trigger inner label print orders during shelf-life revision, in addition to the already supported outer label printing. This is configured at the depot level, and the relevant BOM structure is used to determine the label components, printing supplier, and printing location. For clinical supply teams operating in regulated European markets, this eliminates a manual gap in the shelf-life revision process and ensures that updated expiry information reaches both the outer and inner packaging consistently and compliantly.
New PCN Changes App
The new Fiori app “PCN Changes” provides a full change log for Packaging Control Number (PCN) objects, capturing events from creation through batch changes, approvals, releases, and medication number assignments. It includes changes made both directly in the PCN and via the Clinical Supply Orders app, and can be filtered by study, protocol, responsible employee, PCN status, and more. By bringing all PCN-related change history into a single dedicated app, quality and supply teams can respond to audit requests faster and with greater confidence without having to piece together information from multiple sources.
Reversal Process: Purchase Order – Inbound Delivery
Incorrect medication kit assignments during the Purchase Order – Inbound Delivery (PO-IBDL) process have historically required complex manual corrections. Release 2605 introduces a complete rollback capability for this process: when an inbound delivery is deleted, the system guides the user to also mark the related PO item as deleted and release a new one. The incorrectly assigned Medication numbers are automatically restored to status “Available”, so they can be reused in a subsequent Purchase Order, eliminating the need to generate new numbers. Throughout the entire reversal, a full change log is maintained on the impacted Medication Kit, ensuring complete traceability for compliance and audit purposes.
Reversal Process: Initial Stock Upload
Similar rollback capabilities are now also available for the Initial Stock Upload process, covering both SAP Inventory Management (IM) and SAP Extended Warehouse Management (EWM) locations. If medication kits were incorrectly assigned during an initial stock upload, the process can now be fully reversed: the goods movement is cancelled, the medication kit is reset to an undefined state, and the previously assigned medication numbers are returned to “Available” for reuse. As with the PO-IBDL reversal, the complete change history is preserved on the medication kit throughout, giving quality and supply teams the audit trail they need without any manual workaround.
Bucket Value Configuration Refinements
The Bucket Value Configuration has been substantially simplified and hardened in release 2605. A new SAP-delivered switch business configuration set provides a minimum viable example out of the box, covering 10 common use cases mapped to 7 bucket values, giving new implementations a solid starting point without needing to build everything from scratch. Validations have been added to restrict configuration entries to supported movement types only, preventing misuse in unsupported scenarios. Several previously configurable behaviors are now automatic: reversal postings restore the previous medication kit status without any configuration entry, and the “In Rework” (INRE) bucket value no longer needs to be maintained in the config table at all.
The configuration table itself has been renamed to Map Stock Buckets and Status to Goods Movement Type and Reason for clarity.
Release 2605 delivers meaningful improvements across the SAP Intelligent Clinical Supply Management solution, from smarter study and scenario management to tighter compliance controls, richer audit trails, and a more consistent user experience. Whether you are a trial manager, supply planner, or system administrator, this release has something that makes your day-to-day work more efficient and more reliable.
Please keep in mind that this blog only summarizes the release highlights. To explore all the details, refer to the official release documentation on the SAP Help Portal.
We look forward to hearing your feedback – feel free to leave a comment below or reach out to the product team directly.
