IN PARTNERSHIP required? • How will the comparator be used?


Countries participating in the trial: • Which countries are participating in the trial?


• Which documents are required for import and export?


• How much of the comparator product can the local market supply and at what price?


Comparator evaluation: • What is the delivery time frame for the duration of the study?


• Is there a generic form of the comparator product available?


• Who is the manufacturer and where is the product manufactured?


• Are there shortages or expiration concerns associated with the product?


Market versus manufacturer comparator sourcing strategies


Each clinical trial has its own unique complexities. It’s vital to consider multiple


options in order to choose the most efficient and cost-effective route to source comparators. There are two strategies to consider when sourcing a comparator: market versus manufacturer sourcing. Market sourcing means approaching a wholesaler in order to source the comparator product, while manufacturer sourcing means approaching the innovator company for its comparator product. Which strategy we use can be affected by: • Documentation: certificate of analysis (CoA) is available for some products and markets, but can be more difficult for rare or expensive medication. Extensive documentation can only be feasibly obtained from the manufacturer.


• Expiry: when sourcing from a manufacturer, they can often offer longer expiration dates than when sourcing products on the open market.


• Batches: large quantities of rare medication can be in multiple batches, which can complicate the packaging and labelling process.


18 | Outsourcing in Clinical Trials Handbook


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