Our On-Demand model
The Clinigen Clinical Supplies Management team is reinventing the clinical trial supply chain with our innovative On-Demand services. We recognise the packaging and labelling obstacles you face for your clinical trials, from time constraints to study changes that cause re-work and waste.
With Clinigen’s On-Demand method, you will be able to shorten timelines, reduce clinical trial costs, and increase the flexibility of your study so as to directly tackle any packaging and labelling difficulties from the start.
On-Demand and study enrolment
On-Demand focuses on actual enrolment, allowing your company to start a clinical trial in just a few weeks because we recognise the urgency of time in regards to your clinical trial processes. Therefore, our On-Demand methods include the packaging and labelling of clinical supplies specifically for, and immediately prior to, each shipment request.
Additionally, we make sure your On-Demand request will be processed and shipped between 48-72 hours every single time; standard turnaround time depends on your location (EU or US). Also, please review our On-Demand Services Case Study for more in-depth information on this innovative clinical trial logistics service.
On-Demand and waste reduction
Even with expense forecasting and implementing lean from the beginning, more than 25% of all clinical supplies that are packaged and labelled are never used. On-Demand packaging and labelling of clinical trial supplies specifically for, and immediately prior to, each shipment request eliminates this waste. This allows you to save more than what you spend to package the entire clinical trial. It also reduces storage and inventory and makes adaptive trials possible.
While our clinical packaging & labelling methods are appropriate for small to large-scale trials, certain trials involving expensive and limited supply medicines can greatly benefit from the On-Demand method.
As an example: In a recent study, a comparator drug of $5,000 per unit was ordered and dispensed On-Demand. Since much smaller quantities of the drug were needed, using On-Demand saved almost 70% compared to the traditional method.
For more information about how Clinigen’s innovative clinical supplies management solution will aid your team in shortening timelines, reducing costs, and increasing the flexibility of your study, read this article.
On-Demand services: features and benefits
On-Demand clinical trial supplies are packaged and labelled after the receipt of the shipment request.
This process requires much less bulk drugs at the start. In fact, bulk drugs 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 labelled. This can apply to primary packaging as well as secondary packaging. The clinical trial supplies are prepared and shipped between 48-72 hours.
The On-Demand Workflow for Clinical Trials
Within 24 hours, the following services will be automatically provided:
- Request: An IWR/IVR requests specific kits/blocks via fax or email. We can also customise this process in the event you aren't using an IWR/IVR.
- Dispense: The requested kits are packaged and labelled upon receipt of the request under cGMP conditions and are 200% checked for accuracy before release with an additional 100% oversight and final release by Quality Control.
- Ship: Up to 5 working days upon request, clinical trial material is shipped overnight to study sites in a protocol-specific pack out.
The On-Demand Difference
- Provides flexibility in product use
- Adapts easily to change and eliminates duplicate work
- Reduces drug waste
- Eliminates need for packaging campaigns
- Accommodates change without compromising the trial timeline
- Reduces storage and inventory
- Makes adaptive trials possible
- Greatly lowers the costs associated with clinical trials
Like our clinical packaging and labelling offering, our On-Demand service is responsibly performed under cGMP conditions and diligently follows the requirements of 21 CFR 211 and Annex 13.
The Clinigen team recognises the packaging and labelling obstacles you face; from time constraints to study changes that cause re-work and waste. With Clinigen’s On-Demand method, you are able to shorten timelines, reduce costs, and ultimately increase the flexibility of your study.
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As a leading provider on a global scale, Clinigen is committed to delivering fully integrated logistics services to our clients. Over 80% of the studies we are supporting are multi-national and we organise shipments to 110+ countries.