On-Demand Packaging & Labeling

On-Demand is the next generation of CTM packaging and labeling. It is the packaging and labeling of CTM for a specific subject or block of subjects, upon request. This is a significant departure from traditional packaging and labeling in that clinical supplies are made specific immediately prior to each shipment instead of being prepared en masse prior to 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 companies to:

• Shorten the timeline for starting a study. Assuming that label text has been approved and bulk drug product has been released, the typical lead time for On-Demand packaging and labeling is 2-3 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 and drugs and comparators that are expensive.