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Risk management of clinical trial supplies
As a global science-based leader in clinical trial supplies, Clinical Services International (CSI) has an in-depth knowledge of the risks involved when sourcing comparator or co-medication in clinical trials and the strategies needed to overcome them.
Complexity in clinical trials has increased over the past few years, and mitigating risks that could impact patient safety, study budget, overall duration or even threaten the outcome of the study is essential when preparing your Due to severe market competition, the number of comparator studies is increasing, and the demand for comparator drugs is growing. While most sponsors agree that they add value, they also add new challenges to the clinical trial supply chain. As such, risk mitigation in this area has become crucial. chain and, according to recent surveys, the biggest challenges in comparator supplies are related to the availability of comparator
Drug shortages have been the focus of the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and sponsor organisations for years – and the COVID-19 pandemic. The global pandemic was a stress test and has led to rising demand for certain medications while further limiting the availability of others. Drugs that are in short supply often include sterile injectables and potentially life-saving oncology treatments Besides the lack of available effective drug treatments, other areas of a clinical trial can be impacted, including medical procedure interruptions, treatment protocol delays, rates of medication errors and patient health outcomes. As a result, sponsors have
20 | Clinical Trial Supply Handbook
experienced a negative impact on their clinical
A lack of comparable drugs and/or co- medication in the market where they were impact on clinical supply strategies, including timelines and costs. Therefore, it is important to be aware of the risk and to consider bringing other options, including back-up alternatives, If the material can be sourced from other
markets, it is critical to understand the
Regulatory requirements are paramount when working on alternative sourcing strategies. Do you need to update your investigational new drug (IND) and include the information in an attachment to the IND, or does the entire IND need to be rewritten and submitted? Is the product additional documentation to provide proof to regulatory authorities? Are the same documents and information available when sourcing material from a different market? All
Importing the material from another market requires a thorough understanding of the paperwork and import process (eg, timelines, importers of record, etc) that are needed. It is also pertinent to consider risks such as delays
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