The Supply Chain is often an afterthought when managing Clinical Trials. Where the devil is in the details, having a lack of resources to manage your Clinical Supplies can result in a detrimental loss to your Clinical Trial Study. It’ll likely result in a negative impact to your bottom line and your drug won’t go to market as planned.
At a high-level, the top factors that you need to consider:
- Regulation
- Environmental Factors (Temperature and Expiration)
- Forecasting Enrollment
- Deadlines/Time Constraints
Regulation
On the logistics side, regulation has always been a pain point, but with the rise of Globalization comes new challenges. Companies must be knowledgeable in Global regulations that cover packaging, labeling, and product handling. Due diligence must be exercised and preliminary work must be completed in order to ensure compliance with local regulations. Typically, documentation has proven to be an area of oversight that has resulted in costly consequences. For example, with the arrival of shipment, your product will be on hold until you can produce the appropriate documentation. To reduce friction in the supply chain, you would have had to produce the documentation ahead of time to avoid holds on your product. Without it, your product could spoil due to time constraints or your deadlines won’t be hit due to delays. Another example of regulations in a global market, the EU, requires that a QP (Qualified Person) perform audits of all facilities involved prior to the release of incoming materials, highlighting the need for depots (Dreifke, 2015). Depots are utilized to ensure cost-effective and efficient delivery. The catch with depots is that they will also need to be prequalified and are required to be GMP-compliant storage facilities.
Environmental Factors
Environmental factors that must be accounted for in distribution are temperature and drug expiration. According to a survey based on 15 clinical study companies, only 2/3 of all products shipped to clinical sites were dispensed to patients (Korieth, 2017). You’ll need to qualify drug packaging and the insulated shipping containers as well as any other storage/distribution points that your drug will interact with. To account for these factors, mechanisms such as delivery confirmation, the condition of received goods and temperature conformity should be implemented prior to initiation of distribution.
Enrollment Predictions
Enrollment predictions have been a persistent pain point where 62% of materials that have been packaged for studies were not used by patients (Koreith, 2017). Inaccurate enrolment predictions are costly and often result in overages of supply at one site and shortages at another site. Contributing factors that act as barriers to accurate enrollment predictions are:
- Competitive enrollment practices across different sites for the same organization will make it harder to discern where resources should be allocated
- Changes in protocol and study parameters starting at the startup phase and throughout the trial period
A common strategy that teams typically use is to produce overages as a buffer. This strategy isn’t particularly ideal as it incurs additional cost and waste.
A solution that is recommended to address the challenges is leveraging an Interactive Response Technology (IRT) system. An IRT system:
- Helps to improve supply chain planning
- Allows for flexibility, which is key in adaptive clinical trials
- Identifies and limit factors that contribute to waste
- You can scale systems according to company needs and you do not need to use the full system
Weighing the costs with the benefits will be crucial in the evaluation of an appropriate IRT system.
Time
Time is a pain point for many companies because you will require time to deal with the above pain points. Sponsors are increasingly developing partnerships with a small number of full-service contractors for multiple functions in order to simplify supply chain management (Lis, et al., 2009). Full-service providers are equipped with resources, experience and compliant with regulations to help you execute your clinical trials efficiently.
Taking your drug to market involves a combination of Supply Chain Logistics and drug product knowledge in order for your drug to go to market successfully. Supply Chain Logistics is typically not a priority that comes to mind, but it should be a thought out procedure to ensure your investments and work on the drug product make it through the Clinical Trials.
