Clinical On Demand Labeling And Packaging

On-Demand is the packaging and labeling of clinical trial materials (CTM) for a specific subject or block of subjects, upon request.

This is a significant departure from traditional packaging and labeling. On-Demand clinical supplies are made specifically for, and immediately prior to, each shipment – instead of preparing the entirety before the first shipment. Like traditional packaging and labeling, On-Demand Packaging and Labeling is cGMP compliant and requires the use of approved pre- and post-production batch records.

Clinical supplies operations are often the rate-limiting step in drug development. CSM®'s On-Demand Packaging and Labeling service offers a way for you to:

• Shorten the timeline for starting a study. When label text has been approved and bulk drug product has been released, the typical lead time for On-Demand Packaging and Labeling is two to three weeks.
• Reduce costs associated with unnecessary overages and re-packaging/re-labeling efforts, storage and end-of-study waste. Because supplies are prepared only as needed, study changes affecting clinical supplies (such as changes in dosage regimen, label text, packaging design, number of sites, patient enrollment, expiration/re-assay date) may be implemented almost immediately with minimal waste.
• Increase the flexibility of bulk and clinical supply inventories. Bulk inventory is stored at CSM and can be packaged and labeled on demand for multiple studies, thus resulting in highly customizable supplies. The need to forecast the quantity of bulk drug to be packaged and the errors associated with this forecasting are eliminated.
• Reduce bulk and comparator drug requirements. Forecasted overages for CTM are typically 50-200% — eliminating this overage results in a significant benefit for study drugs in short supply, as well as drugs and comparators that are expensive.