In today’s global market, clinical trials are rarely isolated to one location
Most clinical trials span many countries and regions, which requires comparator sourcing partners to have a global reach. Country-specific expertise and strong relationships with suppliers and manufacturers enable partners, like Clinical Services International (CSI), to source comparator drugs globally while maintaining regulatory compliance and maximising cost savings.
Here are four reasons why having a global comparator sourcing network is beneficial:
Identify opportunities for cost savings
As a comparator sourcing partner, we use knowledge of global markets to choose the most appropriate sourcing strategy, whether it is local, central, market or manufacturing sourcing. By weighing up the appropriate strategies, we can identify where your company can save resources. For example, sourcing from the market that the trial is conducted in or sourcing products in one country and shipping for use in other countries.
Typically, oncology drugs are less expensive to source in regions such as Asia and Latin America than in the United States or Europe. This is caused by the differential costs of local sourcing. On the other hand, exporting and importing comparators from emerging regions may bring with it higher distribution and logistical costs. Rather than sourcing comparators in established markets, we can source products from emerging regions and create cost-saving opportunities for your business.
Remain compliant with regulatory requirements
Regulations and legislation can differ greatly from country to country. When clinical trials are conducted in multiple countries, we need to be aware of the governing bodies and regulatory differences that may impact the conduct of the trial. This can include factors such as import, export, data, ethics and logistics.
A global reach enables us to understand dynamic clinical trial approval processes, regulatory requirements and language barriers. We can obtain the right documentation, such as certificates of analysis, and translate it into the appropriate language that will successfully demonstrate the chain of custody from the source to the final destination. This avoids misinterpretation and ensures we maintain compliance throughout the trial process regardless of the participating countries.
Substantial comparator availability
Availability of comparator drugs in the United States or Europe can often be scarce. This is typically due to high demand and obstacles with the manufacturer limiting supply to the open market to keep product exclusivity. If this occurs, we often turn to other global markets to source the comparator product, where demand may be less and there is sufficient availability of the drug required for trial.
Excellent relationships with audited suppliers, manufacturers and wholesalers across the world help us source products that would otherwise be unavailable in established markets. Our country-specific knowledge of regulations then enables us to identify whether the products can be exported and imported successfully, all while considering the trial design and logistics, such as product blinding.
Delivery within the required timeframe
When sourcing comparators from emerging regions, there is a risk that the product may not reach the trial site for use in the study within the product expiration date. This can be due to complications such as Brexit when gaining approval to import and export comparators into other countries.
Using our global expertise, we can forecast the supply chain, communicate with local suppliers and manufacturers to overcome challenges, choose the appropriate strategy and deliver the product within the required timeframe.
CSI is a world-leading comparator sourcing partner
Working with a comparator sourcing partner like CSI will streamline your clinical trial supply chain and ensure high-quality comparator drugs are sourced in a timely and cost-effective manner.
While our headquarters are in London, we operate in the UK, Germany, Japan and the USA. We leverage our global network and country-specific expertise to source comparator drugs from audited suppliers, originators and dedicated wholesalers in Europe, the USA, Latin America and the Asia Pacific (APAC) while maintaining regulatory compliance.
Contact us to discuss how we source comparators globally to ensure the successful supply of your clinical trials.