A well-designed clinical trial with a knowledgeable team can still stall due to the lack of a comparator medication. A single missing vial can stop a clinical site from performing on a study. Patients may be ready to be enrolled, and research staff may be onsite and ready to perform, but without a comparator, the site is unable to administer the study drug.

For the sponsor, supply isn’t usually the most visible part of a study, but a disruption can quickly threaten the study timelines. How can sponsors prevent one missing product from disrupting a study through better comparator sourcing for clinical trials?

Clinical Trial Supply Must Keep Pace With the Protocol

Clinical trial supply encompasses more than shipping product. Sponsors must consider a multitude of factors to be prepared to respond to changing study and supply demands. There may be adequate supply for a study at the outset, but changes during the study may necessitate a revision of the original plans.

What happens if one study site enrolls patients faster than expected? What happens if a certain product is unavailable in certain countries? These, and similar, issues create delays if sourcing options have not been evaluated.

Neunco’s clinical trial supply services include sourcing comparators and RLDs. Its options include sourcing at the country level, single- or multiple-batch orders, specific batch numbers, varying pack quantities, longer shelf lives, and packaging as directed.

Comparator Sourcing for Clinical Trials Can Become a Bottleneck 

In an active-controlled study, the sponsor’s investigational drug is compared to an established treatment. The established treatment is called the active comparator. The active comparator is only a reference point if the product is sourced and available.

The challenge grows when a study spans several countries. Globalisation has added layers of complexity around international trading and cross-border regulatory and availability hurdles. A comparator that is easy to buy in one market may be harder to obtain in another, and product specifications, import rules, and regulatory expectations can vary. Relying on a single sourcing route adds exposure if availability changes.

Sponsors should consider comparator sourcing well before the first shipment is needed. Comparator supply decisions are often made too late, even though they are becoming more critical to trial success. Neunco describes its global sourcing network as a way to compare routes, identify risks, and propose strategies for each study.

A Missing Comparator Can Cause More Than a Delivery Delay

Consider a trial running across several countries. One site is approaching its next treatment visit, but its comparator shipment is late. A locally bought alternative can’t simply replace it until the team confirms the substitute meets the protocol and regulatory requirements.

The site may need to reschedule treatment activities. The sponsor may need to review stock and consider other routes. Teams may also face added logistics costs and timeline changes. Each of these steps takes time, which is why early planning matters.

Comparator availability is a planning issue as well as a procurement one. Decisions about sourcing countries, batches, documentation, and delivery schedules made early can reduce these risks.

Storage and Distribution Also Matter

Some products need refrigerated or frozen storage, while others must stay within set ambient conditions. Poor handling can raise quality concerns.

Neunco states that its facilities include an EU GDP-certified warehouse in the Netherlands and a licensed distribution centre in New Jersey, USA. It also says it works with logistics partners that offer temperature-controlled transport.