As the global wound care market expands, many sponsors are tempted to pursue large, multinational trials. But when it comes to clinical development for wound care products, a global approach without regional nuance can lead to inconsistent data, regulatory delays, and missed opportunities.

In this blog, we explore why localized development strategies are essential for success in wound care—and how to align your trial design with the realities of each target market.

1. Standard of Care Varies Widely by Region

One of the biggest challenges in global wound care trials is the lack of a universal standard of care. Treatment protocols, product availability, and clinical practices differ significantly between countries—and even between sites within the same country.

For example:

• In the U.S., advanced wound dressings and negative pressure wound therapy (NPWT) are widely used.
• In parts of Europe, reimbursement policies may limit access to certain biologics or devices.
• In emerging markets, basic wound hygiene and dressing changes may be the primary standard.

This variability can introduce data noise, making it difficult to compare outcomes across regions or meet regulatory expectations.

2. Infrastructure Gaps in Emerging Markets

While global trials may seem appealing for enrollment speed or cost savings, infrastructure limitations in some regions can compromise trial quality. These include:

• Limited access to digital wound measurement tools
• Inconsistent training and protocol adherence
• Gaps in data capture and monitoring systems

For wound care products—where healing rates, infection control, and dressing changes must be precisely tracked—these gaps can lead to incomplete or noncompliant data.

3. FDA vs. EMA vs. PMDA: Regulatory Expectations Differ

Each major regulatory body has its own expectations for wound care product development:

• FDA (U.S.): Emphasizes objective endpoints, validated measurement tools, and robust safety data. Often requires pre-IND or pre-submission meetings.
• EMA (Europe): Focuses on clinical benefit and cost-effectiveness. May allow more flexibility in trial design but expects strong post-market surveillance.
• PMDA (Japan): Requires detailed documentation and often prefers local clinical data. Early engagement is critical for combination products or biologics.

Understanding these differences is key to building a regionally compliant and globally scalable development plan.

Localized Execution = Global Success

To succeed in wound care clinical development, sponsors must think globally but execute locally. That means:

• Designing trials that reflect regional standards of care
• Selecting sites with proven infrastructure and training
• Aligning with local regulatory expectations from day one

At Amarex, we specialize in regional trial strategies across the U.S., EU, Canada, and Japan—where infrastructure, regulatory clarity, and data quality are strongest.Talk to Our Global Strategy Team]

Let’s build smarter, regionally optimized trials that deliver global impact.