Rescue Studies in Oncology: Turning Around Challenged Clinical Trials

Overcoming Roadblocks in Early-Phase Oncology Trials

Clinical trials are essential for advancing cancer treatments, but not all trials go as planned. Regulatory delays, enrollment challenges, site performance issues, and protocol deviations can put a study at risk. That’s where rescue studies come in—designed to strategically intervene and get struggling trials back on track.

At Winniedel Oncology, we specialize in expediting study start-up (SSU) and optimizing early-phase (FIH-2b) oncology trials. Our expertise in rescue studies ensures that promising therapies don’t stall due to operational inefficiencies.

Why Do Clinical Trials Need Rescue?

Several factors can lead to the need for a rescue study:

• Slow patient enrollment – Many trials struggle to meet enrollment goals, delaying drug development.

• Underperforming trial sites – Some sites fail to meet recruitment or data quality standards.

• Regulatory and compliance setbacks – Delays in approvals and protocol amendments can halt progress.

• Insufficient site support – Lack of engagement, poor communication, or inadequate training can impact trial success.

How Winniedel Oncology Executes a Rescue Strategy

Our team specializes in rapidly assessing and addressing the root causes of clinical trial challenges. Here’s how we do it:

Rapid Assessment & Root Cause Analysis

We thoroughly audit the study’s current status, identifying bottlenecks and areas for immediate improvement.

Site Optimization & Expansion

With access to 250+ clinical trial sites across 28 countries, we match the trial with high-performing sites that specialize in oncology research and have access to the right patient populations.

Accelerated Study Start-Up (SSU)

Our streamlined SSU process ensures that new sites are activated quickly while maintaining regulatory compliance.

Enrollment Acceleration

We implement data-driven recruitment strategies, leveraging site relationships, digital outreach, and real-time enrollment tracking to boost patient participation.

Enhanced Site Support & Training

We optimize site performance and data integrity by improving site engagement, offering targeted training, and ensuring clear communication.

The Impact of a Successful Rescue Study

When executed correctly, a rescue study can mean the difference between trial success and failure. By partnering with Winniedel Oncology, sponsors gain a strategic advantage in ensuring their oncology trials stay on course. Our proactive, hands-on approach reduces delays, enhances data quality, and ultimately brings life-saving treatments to patients faster.

Are you facing challenges in your oncology trial? Contact Winniedel Oncology today to discuss how our rescue study expertise can help.