Updated: Aug 27
CSI’s expert risk management strategies
One of the biggest challenges faced by clinical trial supply management companies are drug shortages in the supply chain. The FDA Drug Shortages list currently includes Carboplatin, Paclitaxel and Fludarabine oncology medications, and there has been a notable increase in the number and frequency of such shortages. When it comes to drug shortages, there are several contributing factors, including disruptions to manufacturing and supply, regulatory issues, fluctuations in market demand, and pricing and reimbursement policies:
Manufacturing and supply issues are the main cause of drug shortages and can be the result of a scarcity of raw materials, or logistical and business errors.
Regulatory and quality control issues arise when agencies impose restrictions or require additional safety measures to ensure the quality of the medications, which can delay their production and distribution.
Seasonal demand and increased demand, especially during epidemics or pandemics, can lead to medicine shortages in specific regions.
Pricing and reimbursement policies are another major reason for medicine shortages: when the price of a medication is too low, manufacturers may choose to stop producing or reduce the amount they produce, which can lead to shortages in the market.
The effects of these shortages can result in life-saving medications becoming unavailable to patients, risking their treatment and the outcomes of a clinical trial. In a worst-case scenario, drug shortages can lead to increased study timelines and costs.
Clinical Services International (CSI)’s solution? To deliver proactive strategies and interventions that counteract the risk of drug shortages.
CSI has the expertise We leverage longstanding relationships with manufacturers who have global coverage to enable better access to medications with low availability. Communication with the drug manufacturer ensures early identification and resolution of any potential supply chain issues. CSI has qualified over 95 leading manufacturers globally, maximising our access to even the most hard-to-find medicines. Early-stage planning With our logistical expertise and in-depth knowledge of drug development cycles, we ensure there is enough time to source the required medication for the duration of a clinical trial. CSI will propose a reliable sourcing model to provide sufficient quantities of the drug at the right time. Diversifying sources of medication Diversifying the sources of medicine procurement can reduce risk by avoiding the need to rely solely on one source of supply. CSI identifies the best sourcing strategy and alternative drug sources in case the primary supplier experiences any issues. These can be local or global, and a backup plan will always be in place to ensure a consistent supply of medication.
By following these guidelines, CSI minimises the risk of medicine shortages and helps to ensure the smooth running and success of clinical trials around the world.
Read more about how CSI has overcome drug shortages by leveraging relationships with multiple manufacturers. Contact us to find out how CSI’s team of experts can with assist your oncology trials.