The success and failure of a study is closely linked to the effective management of drug supply. Short timelines, complex packaging requirements and mid-study changes can have a negative impact on the study momentum and budget.
Choosing the right packaging and labeling process is critical to efficiently meet the challenges. While traditional clinical supply management methods may be appropriate for some companies, others such as biotech companies where saving time and money is important can greatly benefit from On-Demand.
On-Demand supply services follow the practice of pharmacy’s methods of dispensing medication only after receiving the patient’s prescription from a doctor. A single pharmacy can dispense hundreds of prescriptions each day with limited staff making it a very scalable and decentralized process.
With the On-Demand method, clinical supplies are packaged and labeled after the receipt of the shipment request:
- As with Traditional methods, bulk drug must be in inventory before the On-Demand process can begin but contrary to the traditional method, much less bulk drug is required at the start. In fact, bulk drug could be continually received in small allotments without affecting the On-Demand process.
- Once a shipment request is received, only the requested quantity is packaged and labeled. This can apply to the primary packaging as well as to the capsules and tablets.
- The clinical supplies are usually prepared in an hour and shipped within 48 hours.
Traditional packaging and labeling consists of preparing either all or a forecasted allotment of clinical supplies prior to the receipt of a shipment request. It normally takes 6-8 weeks to get supplies packaged, labeled, released and ready for shipment. Even with expense forecasting, scheduling of campaigns, and implementing lean, more than 25% of all clinical supplies that are packaged and labelled are never used; for most companies it is closer to 50%. In addition to being time consuming and creating waste, the traditional method constantly requires re-work due to mid-study changes.
On-Demand Saves Time, Space and Money
On-Demand is highly flexible and customizable, and rarely automated as the quantities packaged, labeled and shipped are usually small and variable. On-Demand uses Quick Response Manufacturing processes that go beyond Lean and Six Sigma. It’s an innovative method that helps meet the challenges and limitations associated with the traditional packaging and labeling model.
How? There is no need to:
- Prepare supplies in advance, eliminating waste and storage costs
- Forecast how much to package and label
- Schedule production weeks in advance
- Re-work supplies due to retest issues
- Worry about clinical study changes as they can be incorporated in days
There are no limitations to CSM’s On-Demand supply services, other than fear. Every aspect of the clinical supply chain is disrupted to be more cost and time effective.
We recognize the packaging and labeling challenges you face and can help you customize your supply chain so you can efficiently meet your study-specific needs.
Want to learn more about the On-Demand method? Download CSM’s case study to learn how CSM helped a sponsor package and label an investigational medicinal product (IMP).