When sourcing a comparator for your study, you need to ensure you are sourcing the correct product for your requirements, including the right market, the correct quantity, documentation, and shelf-life.

Comparators are used in active controlled Clinical Trials, and availability needs to be ensured. This is especially important if multiple sites are being used.

Comparator sourcing for clinical trials therefore goes beyond purchasing medicines. It calls for early market assessments, careful demand forecasting, regulatory planning, and coordination between procurement and distribution teams.

Why Plan When Sourcing Comparators?

Availability can vary depending on where you source your comparator. You may find that it is readily available in one country, but restricted in another.

Multi-national studies can be complicated. Some studies may require products from certain countries, specific batches, or identical formats for all sites.

Shelf-life can be an issue. You may find that there isn’t enough shelf-life remaining on the product to cover the treatment period, and this can cause issues when trying to source extra product.

It is important to find a supplier who can provide the product. But it is also important to ensure that the product available meets the requirements of the study and regulations.

Planning will make this easier.

What Happens When Comparator Sourcing Starts Too Late?

If you don’t plan when sourcing comparators, you won’t have as much flexibility with unexpected issues.

You may have a multi-national study that requires a specific format. You may find that the market you want to source from doesn’t have enough product.

This can cause issues. You may need to find another market, new suppliers, or check alternative batches. All of this can take time to check documents, qualify the supplier, check if they can be imported, and change your shipping plans.

It can cause increased costs. If you need an expedited shipment, lots of small orders, or extra coordination.

Whilst you can’t always predict shortages, knowing where potential limitations may occur will give you extra options.

For a closer look at supply disruptions, read Why Your Clinical Trial Could Stall Over One Missing Comparator.

Five Steps to Plan Comparator Sourcing Early

1. Forecast Requirements Across Study Sites

Start with the study’s expected demand.

Patient enrolment, dosing schedules, treatment duration, and participating sites all influence comparator quantities. Appropriate buffer stock should also be considered.

Forecasting does not end when procurement begins. Recruitment may progress faster or slower than expected, changing both demand and expiry considerations.

2. Assess Availability in Target Markets

Where can the required comparator be sourced, and in what quantities?

The answer depends on product strength, presentation, market availability, and study-specific requirements.

Country of origin, batch numbers, and minimum remaining shelf life may narrow the options. Identifying these restrictions early helps sponsors evaluate realistic sourcing routes and procurement lead times.

3. Verify Documentation and Regulatory Requirements

A commercially available product is not automatically suitable for clinical trial use.

Before procurement, sponsors should assess product authenticity, traceability, applicable import authorisations, and supporting quality documentation.

Depending on the product and destination, relevant Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) requirements must also be considered.

The European Commission’s guidance on Good Manufacturing and Distribution Practices provides information on these pharmaceutical quality and distribution standards.

4. Evaluate Alternative Sourcing Routes

Relying on one sourcing market can create vulnerabilities, particularly when product availability is limited.

Where practical, sponsors should evaluate additional qualified suppliers or markets before a shortage occurs.

However, an alternative source is not necessarily an interchangeable solution. Different batches or products must still satisfy study specifications and receive any necessary approvals before use.

The objective is to establish suitable options, not simply a longer supplier list.

5. Coordinate Storage and Distribution

Sourcing the comparator is only part of the supply process. It must also reach the intended destination under appropriate conditions.

Some products require refrigerated or frozen storage. Others may need temperature monitoring during transportation.

Shipment schedules, customs procedures, remaining shelf life, and site requirements should therefore be considered alongside procurement.

Early coordination between sourcing and logistics teams helps establish a practical distribution plan.

How Neunco Supports Comparator Sourcing for Clinical Trials

Neunco provides pharmaceutical sourcing and distribution solutions for sponsors and CROs managing international clinical trials.

Through its Comparator and Reference Listed Drug (RLD) Sourcing services, the company supports country-specific procurement, single- and multiple-batch requirements, particular batch numbers, varying pack quantities, and products with longer remaining shelf life.

Its distribution infrastructure includes an EU GDP-certified warehouse in the Netherlands and a licensed distribution centre in New Jersey, USA.

Across its verified storage network, Neunco has access to more than 20,000 pallet positions for ambient, refrigerated, and frozen products. Qualified logistics partners support temperature-controlled international transportation.

Visibility matters throughout procurement, too.

Neunco provides order-status tracking, allowing clients to monitor progress and maintain visibility into their sourcing activities.

By coordinating sourcing, storage, and distribution requirements, Neunco helps sponsors evaluate procurement options while keeping the wider study schedule in view.

Questions to Ask Before Choosing a Comparator Sourcing Partner

Not every supplier is equipped to support complex, multi-country clinical trials. Before making a decision, sponsors should look beyond product availability.

Consider asking:

• Can the required comparator be sourced from a specific country?
• Are particular batch numbers, quantities, and shelf-life requirements supported?
• What documentation is available to establish product authenticity and traceability?
• How are supply constraints or potential shortages communicated?
• Can the partner support the required storage conditions and international distribution?

The answers reveal more than sourcing capabilities. They also indicate how effectively the partner can support changing study requirements.

Plan Early to Protect Your Clinical Trial Timeline

Comparator supply conditions can change. Market availability may tighten, shipment requirements may become more complex, or study demand may shift.

While these risks cannot always be eliminated, early planning creates opportunities to address them before they affect trial operations.

For sponsors running multi-country studies, understanding product availability, documentation needs, batch requirements, and distribution arrangements from the outset can make procurement decisions more manageable.

For related insights, explore Clinical Trial Supply Delays: Common Reasons and How We Can Help.

Neunco supports comparator and RLD sourcing, storage, and international distribution. From country-specific requirements to batch availability and shipment coordination, our team can help you explore suitable sourcing options.