SAP Intelligent Clinical Supply Management is an advanced solution for clinical trials to facilitate study management, demand forecasting, manufacturing, packaging, labeling, and shipments of clinical trial materials.
This blog introduces the highlights of the latest feature release 2306 of SAP Intelligent Clinical Supply Management.
Release Highlight for Study Management and Planning & Forecasting
Supply multiple treatments/dispensations from a bulk kit
During a trial, it can happen that multiple patients at a site are supposed be supplied with the same kit, e. g. that one glass vial contains several doses of vaccine which can be dispensed to different patients.
To cover these scenarios, an additional column has been added to the kit type table where information about the number of units in a bulk kit can be entered. This information becomes available also in the treatment table where you also can enter the number of units to be dispensed per individual.
Possibility of setting up placeholder site groups
When setting up a study, trial managers might not know all site groups of the study yet (site group = set of sites involved in a study that are supplied from the same distributing depot). Therefore, we have introduced the possibility to create placeholder site groups when creating a study. This enables users to start their planning without having the final lists of countries ready. As soon as the country is known, the placeholder can be replaced by the final site group.
Plan studies with switches between randomization groups
When dealing with randomized studies in SAP Intelligent Clinical Supply Management, users define at least one randomization group comprising two or more treatment groups when designing their study. Subjects then are assigned at random to the treatment groups of a randomization group according to the subject ratio described in the study protocol.
With the latest release, it is now possible to maintain relationships between randomization groups and treatment groups. This enables users to model studies with several phases (e.g., if there is a need to switch the placebo group to the active group and vice versa during a study). Of course, it is also possible to plan an additional enrolment for each phase of the study.
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