IN PARTNERSHIP
• Price: manufacturers often quote the highest price in the region. For example, they might quote a German price for an EU sale.
• Disclosure: manufacturers almost always require you to disclose trial details in order to supply the comparator product.
• Availability: the market may not be able to supply the desired quantity of comparator, so it’s important to evaluate which strategy has the required stock.
Local versus central comparator sourcing strategies
Depending on whether the comparators have been sourced direct from the manufacturer or from the open market, products can be sourced and used in one country or sourced and distributed to multiple countries. This is also known as local versus central sourcing. Local sourcing means sourcing a comparator product from the country the medicine is going to be used in. If the product doesn’t need to be blinded, there’s no need to repackage it as it’s already in the local language. There’s also less regulatory pressure surrounding import and export, as the product is commercially available in the country of the trial. Local wholesalers can often supply the comparator at a lower cost with shorter lead times than the manufacturer. Central sourcing means purchasing the
comparator in one country and distributing it to multiple countries for trial. Central sourcing reduces the risk of product stock shortages in one country, which can affect trial progress. It’s also a solution for trials that are complex to source locally – for example, trials in several countries or with multiple co-medications. You can also leverage price differences across markets by buying in a cheap market and exporting to more expensive countries.
Depending on the trial requirements, we
may use a hybrid approach combining local and central sourcing, for example, locally sourcing less expensive, widely available generic co-medication, and centrally sourcing rare, expensive biologics.
CSI is a leading comparator sourcing partner Partnering with CSI at the protocol design stage ensures your trial runs efficiently and successfully. There is no one-size-fits-all approach to comparator sourcing. We devise a bespoke
sourcing strategy that caters to your trial requirements. This is the most effective solution.
1. Strong global network While our headquarters are in London, we operate in the UK, Germany, Japan and the US. We use our global network and country-specific expertise to source comparators from audited suppliers, originators and dedicated wholesalers while maintaining regulatory compliance.
2. Excellent supplier relationships Our excellent relationships with suppliers and manufacturers across the world help us source medications from Europe, the US, Latin America and Asia-Pacific (APAC). Our worldwide access ensures we are compliant with differing regulations across the globe.
3. Country-specific and regulatory expertise We understand the dynamic clinical trial approval processes, regulatory requirements and language barriers, and have access to experienced clinical research staff to ensure you remain compliant throughout the trial process. CSI improves trial success rates by securely sourcing comparator drugs in short supply with the longest expiry, ensuring they’re available for trial participants at the right place and time. By partnering with CSI, your sourcing strategy takes the most appropriate route to improve the speed and agility of your clinical trial.
For more information on how we source comparators globally to ensure the successful supply of your clinical trials visit
csint.com or email
info@csint.com
Outsourcing in Clinical Trials Handbook | 19
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