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Product and Topic Expert
Product and Topic Expert

According to McKinsey, companies that invest the time, effort, and resources in devising their manuf...

Clinical Trials and Efficient Manufacturing and Packaging

Each clinical trial is conducted according to a comprehensive plan or protocol that is designed to assess as many factors as possible in an independent and safe way. The end-to-end execution of a clinical trial, from planning of the study to manufacturing of the clinical products and their distribution to the clinical sites, is a very complex and long endeavor.

Therefore, a manufacturing strategy that optimizes resources, embeds resilience, and confers a competitive edge is increasingly important in the life sciences industry.

An essential factor for a successful clinical trial is the efficient manufacturing, packaging and labeling of clinical trial supplies, especially when you consider the following aspects:

  • Randomized studies require the manufacturing of different treatment kits (active compound, placebos, and comparator drugs).

  • Blinded result in enhanced complexity in primary and secondary packaging as well as the labeling of the treatment kits since this must be done in a way that active and placebo cannot be distinguished by patients or doctors but the “unblinding” can be done correctly wherever needed.

  • Multicentered studies in different locations worldwide require compliance with different country-specific regulations regarding packaging, labeling, and shelf-life management.

  • Shelf-life management is a special challenge in clinical trials. Besides the already mentioned country-specific regulations affecting shelf-life, permitted shelf-life might also change during a study due to new insights about stability and storability of the new compounds. Thus, it might be reasonable to extend the shelf-life of already produced and labeled products.

  • The shift away from simple small molecules towards biologics and complex active ingredients leads to the necessity of specialized manufacturing, distribution, and storage conditions.

  • Complex production processes are leading more and more pharma manufacturers to outsource their production and packaging processes to Contract Manufacturing Organizations (CMOs). This requires the smooth integration of these external contractors into existing processes of the supply chain.

  • The trend towards adaptive trials is further complicating the clinical supply chain since manufacturing, packaging and distribution must react flexibly and quickly towards the changing demands during a study.

The smooth execution of these intertwined processes requires a paradigm shift, away from manual processes using excel lists towards a fully digitized, integrated clinical supply chain. Overcoming these challenges will result in significant competitive advantages for any pharmaceutical company conducting clinical trials viz. lower costs, quicker time-to-market and increased compliance to regulatory changes.

SAP and Tenthpin, together with an industry consortium led by Roche have recognized these challenges and developed an industry standard solution for clinical supplies.

SAP Intelligent Clinical Supply Management consists of several modules covering the whole clinical supply chain: from Study Design, to Planning and Forecasting, Manufacturing and Packaging, and Distribution of the medication to the study sites.

For this blog post, we will concentrate on the Manufacturing and Packaging capabilities of the solution.

Fig. 1: SAP Intelligent Clinical Supply Management – End to end clinical supplies planning, operations and integration into clinical supply ecosystem

How SAP Intelligent Clinical Supply Management Can Help

SAP Intelligent Clinical Supply Management offers capabilities tailored for the specific needs of manufacturing and packaging for clinical trials. The Manufacturing & Packaging module is part of an SAP S/4HANA add-on leveraging existing SAP business capabilities used in commercial supply chains but tweaked with clinical-specific enhancements.

What can the clinical study focused manufacturing enhancements do for you?

The clinical specific enhancements to the standard SAP S/4HANA manufacturing capabilities are targeted to enable streamlined communication of order information and workflow triggers within manufacturing. This not only includes the internal processes but also considers the seamless integration of third parties, such as Contract Manufacturing Organizations (CMOs) or external packaging and labeling providers.

The following sections illustrate the functions that have either been enhanced or developed new for the manufacturing processes in the SAP Intelligent Clinical Supply Management:

Everything You Need, in One Place

All the relevant capabilities for the manufacturing process can be via a configuration. This makes it extremely easy for a production planner or a clinical coordinator to access all the necessary applications on a single system.

The applications are ordered under the Clinical Trial Supply Preparation and Clinical Trial Supply Execution heads.

Fig. 2: Clinical Trial Supply Preparation Apps

Fig. 3: Clinical Trial Supply Execution Apps

Manage your Medication Lists

SAP Intelligent Clinical Supply Management uses randomized medication numbers for serialization. A medication list is a group of such randomized medication numbers that are assigned to a kit type in a particular study. Medication lists can be either manually uploaded as a file or generated automatically using SAP ATTP through the Manage Medication Lists application. The system then runs checks to ensure correct assignment and uniqueness in a study, opening the door for these medication numbers to be used in the production process.

The status of the medication number can be easily viewed from within the app where it displays important information like the kit type, sequence number, current stage of manufacturing and associated Purchase or Process Order.

Manage your Shelf-life Data

The shelf-life data is used to automatically calculate the expiry date of CFG batches during the production and packaging process. Shelf-life versions are sets of regulatory information applicable to a primary pack (PP) material (or where used, a flavor ID) in combination with a specific study, or with a pool ID in the case of pooled materials. The information can be entered and edited manually or via integration with a Regulatory Information Management System (RIMS), or by a combination of both methods.

Manage Shelf-life Data Manually

You can enter and manage country-specific regulatory information for the primary pack (PP) materials of a specific study, including approved, filed and planned shelf-lives via the Manage Shelf-Life Versions application.

You can use this app to do the following:

  • Create a shelf-life version for a combination of study and primary pack material.

  • Enter and edit country-specific shelf-lives.

  • Choose limited, unlimited or no auto-approval.

  • Indicate whether only the Investigator's Brochure is relevant for a country.

  • View the packaging-relevant shelf-lives calculated by the system.

Automatically Update Shelf-life Data through RIMS Integration

Shelf-life information can be provided by an external RIMS. If no active shelf-life version exists for the combination of study and PP material, or of study and flavor ID, received from the RIMS, the system creates one. For each country/region, you can specify whether integration with a RIMS is enabled.

Your Clinical Supplies on your Fingertips

The solution offers a dashboard where you can quickly view the status of all your clinical supplies - Clinical Supply Status Overview app. You can filter the information by responsible person, study status or pool ID and it shows you:

  • What study master data is missing in the Master Data Monitor.

  • The status of supply orders (planned and process orders) for internal packaging.

  • The status of supply orders (purchase orders) for external packaging.

  • A list of orders (process orders) ready for internal production.

  • A list of orders (purchase orders) ready for external production.

  • Orders with issues - orders not linked to a study.

  • Studies with Packaging Control Numbers (PCNs) for which a shelf-life extension is possible.

  • Studies with PCNs for which a shelf-life extension is planned.

Check Master Data Readiness

In the Clinical Supply Status Overview app, the Master Data Monitor card shows the studies for which some master data is still missing. The studies are ordered by First Subject First Visit (FSFV) date, and the degree of completeness of study-related master data is shown as a percentage. You can navigate either from a selected entry on the Master Data Monitor card to see the related issues for a study or navigate from the monitor header to view a complete list of studies with outstanding master data issues.

Supply Monitors for Internal and External Packaging

The entries in the two supply monitors are sorted by due date, with the earliest at the top. The due date is shown in each entry, and whether it is overdue, or how many days are left until the due date. Entries marked Initial Supply indicate the first supply for the study. In other words, no packaging has yet been performed. In these cases, it's possible that not everything is ready to start planning supply.

You can click the Supply Monitor header to navigate to the Clinical Supply Orders app, which lists open supplies for clinical studies.

  • When you navigate from the supply monitor for internal packaging, the list shows only orders for in-house production.

  • When you navigate from the supply monitor for external packaging, the list shows only orders for external procurement.

By default, the list shows only supply orders with status Not Released. You can choose an entry in the Supply Monitor to open the corresponding supply object page in the Validate Clinical Batches and Expiry Dates app.

Label Management

The solution supports complete clinical label management capability through the following two flavors:

Integrated Internal Labeling

SAP Global Label Management (GLM) provides support for both simple and complex labeling processes. It offers multi-lingual phrase management, country-specific regulatory rules specifications, label design, approval workflow for labels, support for blinding information and printing on-site or remotely via print orders.

External labeling

For external labeling, label data, layout management and printing processes are managed externally by third-party solutions like Prisym360 or Nice Label.

In case of booklet labels, the orders to external service providers are placed in a standard way and the packaging material label is received in stock to be used in manufacturing. The check for available materials in stock is part of manufacturing preparation within SAP Intelligent Clinical Supply Management.

In case of overprint, labels carrying data from a manufacturing process preparation step, like blinded expiry date, medication numbers, blinded batch, protocol ID, etc. the data is interfaced to a third-party system during the release of a process order.

Extending Shelf-Life Data

You can update the expiry date for Packaging Control Numbers (PCNs)  that include only orders that have not yet been labeled or packed and have no goods receipt. The PCNs can have status Extension Possible or Open. The new date will then be printed on the kit labels. There are two ways that you can track which clinical batches are relevant for shelf-life extension:

Shelf-Life Extension Possible

You can view studies with PCNs for which a shelf-life extension is possible. Each entry shows the study, the primary pack material, and the number of blinded and open label PCNs.

You can navigate directly from an entry to these app to see the corresponding PCNs and from the card header to the Manage Shelf-Life Extensions app to see all PCNs with status Extension Possible.

Shelf-Life Extension Planned

With this application, you can view studies with PCNs for which a shelf-life extension is planned. Each entry shows the study, the primary pack material, and the number of blinded and open label PCNs.

You can navigate directly from an entry to the Manage Shelf-Life Extensions app to see the corresponding PCNs and from the card header to the Manage Shelf-Life Extensions app to see all PCNs with status Extension Planned.

Manage Relabelling

If an extension of the shelf life of a primary pack material is possible, it might make sense to relabel kits with a later expiry date based on the extended shelf life. That ensures that kits can be used before they expire, reducing waste. Other changes can make relabelling necessary, too, such as changed storage conditions of a material.

PCNs can consist of orders that have already been packed, or orders that are still in preparation. Relabelling is a two-step process, one user sets the status of a PCN from  Possible to Extension Planned, while another user, typically with a different role, initiates the relabelling process.

Connect with External Manufacturers (CMOs)

This solution lets you extend your manufacturing processes to exchange order information with your contract manufacturing partners via published APIs, for both process orders and purchase orders.

Clinical manufacturing and packaging at a glance

The manufacturing and packaging module of SAP Intelligent Clinical Supply Management completes the end-to-end process of accomplishing a cost-effective and well-executed clinical trial. It leverages existing standard applications and components of SAP S/4HANA that are used in commercial supply chain processes and provides specifically tailored enhancements targeting the manufacturing needs of the clinical supply chain.

Its integrations to Contract Manufacturing and Label Management make the need for failure-prone manual interfaces obsolete. There is no need for duplicate data entry or data reconciliation anymore. Thus, it helps the businesses run their end-to-end process operations to plan, source, manufacture, distribute, and reconcile supplies for clinical research and development.

Engage with us

If you are interested in learning more about SAP Intelligent Clinical Supply Management, please consider following the new tag “SAP Intelligent Clinical Supply Management” and also read the previously published blog post in this series here.

We are happy to receive your feedback, questions or thoughts about SAP Intelligent Clinical Supply Management in a comment.