IN PARTNERSHIP
with a comparator sourcing partner, like CSI, reduces risks to the clinical trial supply chain and ensures high-quality comparator drugs are sourced in a timely and cost-effective manner.
Emerging markets in the spotlight Pharmaceutical companies are establishing their presence beyond the traditional regions of the US and Western Europe. Global trials now cover Asia, Central and Eastern Europe, Central and South America and the Middle East. Brazil, China and Russia are the emerging
markets in the spotlight for clinical trials today. Governments in these regions are looking to improve healthcare and grant easier access to treatments to ensure patients receive the medicines they need at an affordable price and in a timely manner. Such opportunities provide pharmaceutical companies with more chances to innovate the market.
Benefits of comparator sourcing in emerging markets In established markets like the US and Europe, sourcing comparators, complying with regulations, and ensuring patient well-being slows down the trial-to-market timeline significantly. In emerging markets, there are many benefits to be gained by sourcing comparator drugs in these regions.
Lower cost of comparator drugs Sourcing comparator drugs in emerging regions such as Asia and Latin America is typically less expensive than sourcing the same drugs in the US or EU. For example, oncology drugs are significantly cheaper to source in emerging regions than in the US or EU due to the differential costs of local sourcing. However, exporting and importing comparators from emerging regions may bring with it higher distribution costs.
Improving quality standards Comparator studies conducted in the US and Europe are exceptionally high quality due to the regulatory and approval processes they must undertake. Emerging markets, particularly China in recent years, have taken steps towards developing safe and transparent regulatory systems. This means that clinical trial sponsors are becoming increasingly confident when conducting clinical trials in emerging regions,
knowing a high level of quality is applied and treatments are up to standard.
Substantial comparator availability The availability of a comparator drug in the US or Europe can often be scarce due to obstacles with the manufacturer limiting supply to the open market. In these cases, it can be easier for the trial sponsor to source comparators in emerging regions to ensure they meet the required supply.
Risks of comparator sourcing in emerging markets Comparator sourcing in emerging markets brings many risks to the supply chain. In order to conduct a successful global clinical trial, it is crucial to work with a trusted comparator sourcing partner to understand and overcome supply chain risks.
Regulatory barriers
Regulations in emerging regions differ greatly depending on the country and its government. The more regions involved in developing, sourcing and distributing a comparator drug, the more regulatory differences will need to be overcome. When sourcing comparators from emerging regions, companies must have a strong understanding of the import and export regulations for each country and the handling criteria for each type of drug delivery to mitigate the adverse effects on the supply chain.
Delivery within the required time frames A major risk in sourcing comparators from emerging regions is delivering drugs in time so they can be used in the clinical trial within the product expiration date. Sourcing comparators locally and using the drugs in clinical trials within the same country can overcome this. However, complications caused by Brexit can lead to delays when importing and exporting comparators into other countries within the required time frame.
Language of documentation
As it is more cost-effective to source comparators in an emerging market for use in another country, obtaining the right documentation from some suppliers can be difficult, or may only be available in the local language. Documentation, such as certificates of analysis, is crucial to show the chain of custody from the source to the final
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