How Amarex Rescued a Wound Care Trial

Clinical trials in wound care are notoriously complex. From variable healing rates to inconsistent site performance, even the most promising studies can stall. In this case, a sponsor’s pivotal trial was on the brink of failure—until Amarex stepped in.

This blog explores how a strategic trial rescue plan, combined with expert regulatory navigation and site reactivation, turned a struggling study into a successful FDA submission.

The Challenge: A Trial in Trouble

The sponsor’s wound care trial was facing multiple issues:

• Low enrollment across key sites
• Protocol deviations and inconsistent data capture
• Regulatory uncertainty after a mid-study design change

With timelines slipping and confidence waning, the sponsor needed a partner who could act fast—and deliver results.

The Solution: Amarex’s Trial Rescue Strategy

Amarex deployed a cross-functional team to assess the trial’s status and implement a comprehensive rescue plan. Key actions included:

Protocol Redesign

We revised the clinical protocol to improve clarity, streamline eligibility criteria, and align endpoints with FDA expectations.

Site Reactivation & Training

Our team re-engaged underperforming sites, provided targeted retraining, and introduced centralized monitoring tools to improve compliance and data quality.

Regulatory Re-Submission

Amarex led the preparation and submission of a revised regulatory package, including updated clinical data and a new statistical analysis plan. We facilitated direct communication with the FDA to ensure alignment.

The Outcome: FDA Approval Secured

Thanks to the rescue strategy, the sponsor:

• Recovered trial momentum within 90 days
• Achieved full site compliance and data integrity
• Secured FDA approval for their wound care product

This case demonstrates the power of proactive clinical operations, regulatory agility, and deep therapeutic expertise in turning around high-risk studies.