A top pharmaceutical sponsor approached us when their global Phase III oncology trial faced significant recruitment delays and compliance issues. The trial spanned 10 countries and required over 500 patients, but fragmented site management threatened the timeline.
Here’s how we stepped in to deliver results.
The Challenge
The sponsor faced these critical hurdles:
- Patient enrollment lagged by 20 weeks, jeopardizing the trial timeline.
- Protocol deviations across multiple sites raised regulatory concerns.
- Disconnected systems led to poor oversight and coordination across 30+ trial sites.
These challenges risked the sponsor’s ability to meet deadlines, increasing costs and delaying potential treatment approval.
Our Approach
We developed a strategic, data-driven plan to address these issues:
1️⃣ Centralized Site Management:
- Implemented a global site management framework to standardize processes across all 30+ trial sites.
- Established real-time monitoring systems to track progress, flag deviations, and ensure accountability.
2️⃣ Recruitment Optimization:
- Designed country-specific recruitment strategies leveraging local outreach campaigns.
- Integrated predictive analytics to identify high-potential sites for faster enrollment.
3️⃣ Compliance and Training:
- Conducted intensive protocol training tailored to each site’s language and regulatory requirements.
- Deployed on-demand virtual training sessions to ensure continuity.
4️⃣ Proactive Communication:
- Introduced a centralized communication hub for seamless sponsor-site collaboration.
- Assigned dedicated regional managers to address site-specific challenges promptly.
Results
Our tailored approach produced remarkable outcomes:
📈 Recruitment Timeline Reduction:
- Completed patient enrollment 35% faster, recovering nearly 7 weeks of delay.
✅ Improved Compliance:
- Reduced protocol deviations by 40%, ensuring smoother regulatory submissions.
💡 Enhanced Site Efficiency:
- Site activation time dropped by 20%, accelerating trial milestones.
🌍 Streamlined Global Coordination:
- Unified processes reduced inter-site discrepancies by 50%, creating a more cohesive trial environment.
Key Metrics (Before vs. After Implementation)
| Metric | Before | After | Improvement |
| Recruitment Timeline | 20 weeks delayed | 7 weeks recovered | +35% |
| Protocol Deviations | 15 per site | 9 per site | -40% |
| Site Activation Time | 12 weeks/site | 9.6 weeks/site | -20% |
| Inter-Site Discrepancies | Frequent | Rare | -50% |
Final Words
Through our data-driven site management framework and proactive communication strategies, we enabled the sponsor to recover critical timelines, enhance compliance, and improve trial efficiency. This case study highlights how effective SMO collaboration transforms trial outcomes.
Testimonial
“Partnering with Kerlo Research was one of the best decisions we made for this trial. Their expertise in site management not only helped us regain lost time but also ensured the highest data quality across all our sites.”
— Director of Clinical Operations, Global Pharmaceutical Company
Are delays impacting your clinical trial timelines?Register with us todayto learn how we can optimize your trials for speed, quality, and compliance.
