Why comparator sourcing is becoming a strategic capability in modern clinical trials

A comparator medicine might appear to be just one component of a clinical trial.

But behind every sourced product sits a growing web of global supply pressure, forecasting risk, regulatory complexity, customs requirements, packaging considerations, and timeline sensitivity that can directly affect study continuity.

What once happened largely behind the scenes is now shaping how effectively studies operate under pressure.

“Comparator sourcing is becoming much more strategic,” says Rachel Dukes, Head of Comparator Sourcing EU at Alcura.

“It’s not just about buying product anymore. It’s about understanding what’s available globally, how to get it where it needs to be, and making sure sponsors are planning early enough to avoid problems later.”

For many sponsors, particularly emerging biopharma companies running increasingly complex global studies, that shift is becoming difficult to ignore.

The global sourcing environment has changed

Clinical trials are becoming more geographically diverse, with growing activity across the Asia-Pacific, Latin America, Africa, and emerging markets.

At the same time, comparator sourcing is operating in an environment shaped by:

• Global shortages
• Pricing volatility
• Complex import/export requirements
• Country-specific regulations
• Changing supply routes
• Increasing competition for product availability

According to Rachel, availability remains one of the biggest challenges facing studies today.

“Since COVID, we’ve seen a lot more shortages, and products are much slower to come back into stock than they used to be,” she says.

“Being flexible and being able to source from different regions is becoming really important to keep studies moving.”

Christen McGowan, Global Director of Comparator Sourcing at Alcura, says the rapid expansion of trials into newer global markets is adding another layer of sourcing pressure.

“Asia has become a very hot market, and I don’t think anyone was fully prepared for how quickly that would happen,” she says.

“As studies become more global, companies are entering markets where supply chains and sourcing routes are still developing. That creates a lot more complexity around planning, timing, and execution.”

Why sourcing now shapes trial strategy

Historically, comparator sourcing was often viewed as a transactional process that happened later in the study lifecycle.

Today, that approach can leave studies exposed when supply pressure increases.

Both Rachel and Christen believe comparator sourcing needs to be considered much earlier — sometimes as early as protocol design.

“One of the biggest issues is that companies often come to sourcing teams too late,” says Christen.

“They may already have decided they want to source locally in every market, but if they’d involved us earlier, we could have helped them understand where the risks and challenges were likely to appear.”

Rachel agrees.

“Getting involved at the protocol stage is really important,” she says. “You don’t want to end up backing yourself into a corner by designing something that becomes very difficult to execute later on.”

Early planning is becoming particularly important as sponsors try to balance:

• Cost
• Speed
• Compliance
• Supply continuity
• Operational flexibility

According to Christen, delays can become extremely expensive very quickly.

“Every day a product doesn’t get where it needs to go can have a huge impact financially,” she says.

“Some industry estimates suggest delays can cost approximately $40,000 per day1 if products are not where they need to be on time for patients. But beyond the immediate cost, the bigger issue is the knock-on effect across the entire study.”

Why is global comparator sourcing more complex than many sponsors expect?

One of the strongest themes emerging across the industry is that comparator sourcing is often far more operationally complex than sponsors initially expect.

“What sponsors want versus what’s actually available in the market doesn’t always match,” says Rachel.

“That’s where you need to start working through timelines, packaging requirements, relabeling, shipping, documentation, and ultimately getting stock where it needs to be.”

In global studies, those challenges can quickly multiply.

Products may need to be:

• Sourced from one country
• Relabeled into another language
• Repackaged to meet local requirements
• Shipped through multiple customs environments before reaching site

“We see this a lot in Europe,” says Rachel.

“You might source product in one country and need to move it somewhere else where the language requirements are different, so relabeling becomes extremely important.”

Documentation and customs processes can also create major delays if not considered early enough.

“Sometimes companies don’t realise there’s a problem until the product is already trying to move through customs,” says Rachel.

“Then suddenly there’s missing paperwork or a country won’t allow importation, and it becomes very difficult to fix at that stage.”

Christen says lead times are another hidden pressure point.

“People often assume products are just sitting on shelves waiting,” she says.

“But you have to find the product, secure approvals, buy it, ship it, and coordinate all the logistics around it. That takes time.”

Why do reactive sourcing models become fragile under pressure?

Both Rachel and Christen highlighted growing concern around “just-in-time” sourcing strategies, which are often designed to reduce upfront costs but can create significant operational risk later.

“In theory, just-in-time sourcing sounds great,” says Rachel.

“But if something goes wrong and you don’t have any flexibility or buffer in your timelines, that’s where studies can get into trouble very quickly.”

Shortages are one of the clearest examples.

“We see situations where supply was available when the study was initially planned, but then shortages happen later and suddenly you need an alternative solution,” says Rachel.

“That might mean sourcing from another country, relabeling product, or potentially switching products altogether.”

Forecasting and contingency planning therefore become critical.

“The more forecast information we have from sponsors, the more effectively we can work with manufacturers and suppliers to secure stock in advance,” says Rachel.

“This becomes especially important in Phase 3 studies, where very large volumes may be needed and production timelines can run into months.”

Christen adds that late sourcing decisions can also increase both pricing pressure and supply chain risk.

“If suppliers know you’re desperate, costs can increase very quickly,” she says. “And if companies start moving into secondary markets at the last minute, there can also be risks around supply chain integrity and traceability.”

Maintaining visibility of where products come from and ensuring supply originates from bona fide sources is becoming increasingly important across global studies.

The patient impact behind sourcing decisions

While comparator sourcing is often viewed as an operational challenge, both Rachel and Christen stress that the impact ultimately reaches far beyond logistics.

“At the end of the day, there’s a patient,” says Christen.

“If patients arrive at site and things aren’t ready, that affects confidence and engagement at what is already a very stressful time in their lives.”

Operational disruption can affect:

• Study recruitment
• Patient retention
• Site confidence
• Timelines
• Potentially wider study outcomes

“Sometimes sourcing teams become so focused on the operational side that they forget the end patient,” says Christen.

“But this work really does affect people’s lives.”

What resilient sourcing models look like

As clinical trials continue to globalise, both Rachel and Christen believe resilient sourcing strategies will increasingly depend on:

• Earlier planning
• Forecasting Flexibility
• Local market understanding
• Strategic partnerships

“I think the companies that perform best are the ones that plan early and build backup options into their strategy,” says Rachel. “If something changes — whether that’s a shortage, regulation, or supply issue — they already have a plan in place.”

Christen says sponsors also need to move away from viewing sourcing providers as purely transactional vendors.

“We really want to be seen as a consultative partner rather than just a bolt-on service,” she says.

“There’s a huge amount of operational knowledge that sourcing teams can bring into study planning much earlier.”

That includes:

• Understanding local regulations
• Managing import/export complexity
• Identifying realistic supply routes
• Forecasting long-term demand
• Helping sponsors avoid fragile sourcing models before studies begin

Looking ahead

As trials continue expanding into newer and more operationally challenging markets, comparator sourcing is likely to become even more complex over the next decade. For sponsors, the implications are becoming increasingly clear:

Comparator sourcing now plays a much bigger role in maintaining trial continuity under pressure.

It’s about building sourcing strategies that remain reliable, compliant, and adaptable under pressure. “I think studies will continue becoming more global,” says Rachel.

“That means companies need to prepare much earlier and think much more strategically about sourcing than they may have done historically.”

Christen agrees.

“The earlier companies involve sourcing expertise, the better positioned they’ll be to avoid delays, manage risk, and maintain continuity throughout the study,” she says.

“Increasingly, comparator sourcing is becoming part of the core trial strategy itself.”

References 1. Need source here for $40,000 per day1