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 impact on the study momentum and budget. Choosing the right packaging and labelling process is therefore critical to efficiently meeting these challenges and mitigating associated risks. While traditional clinical supply management methods may be appropriate for some companies, others such as biotech companies where saving time and money is central can greatly benefit from On-Demand supply services.
On-Demand supply services follow the practice of pharmacies’ 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 decentralised process.
With the On-Demand method, clinical supplies are packaged and labelled after the receipt of the shipment request:
Traditional packaging and labelling 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, labelled, 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 is highly flexible and customisable, and rarely automated as the quantities packaged, labelled 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 labelling model.
How? With On-Demand, there is no need to:
With this method, every aspect of the clinical supply chain is disrupted to be more cost and time efficient. At Clinigen, we recognise that every clinical trial has its own unique clinical supply challenges. This is why our services can be tailored to your supply chain so that you can efficiently meet your study-specific needs and goals.
Interested in learning more about the On-Demand method? Read our case study to learn how Clinigen Clinical Supplies Management helped a sponsor to package and label an investigational medicinal product (IMP) within 48 hours.
As a leading provider on a global scale, Clinigen is committed to delivering fully integrated logistics services to our clients. Over 50% of the studies we are supporting are multi-national and we organise shipments to 85+ countries.