How we helped a biotech innovator overcome clinical trial Obstacles: A journey to success

Challenges Faced by the Client Before Handing Over Project to ProRelix Research

A mid-sized biotech firm was conducting a Phase II clinical trial for an innovative oncology drug aimed at treating advanced-stage lung cancer. However, their study was falling behind schedule, putting their regulatory submission and funding at risk.

Patient Recruitment Was Lagging – Only 20% of the enrollment target was met within the first 6 months. Without a strong recruitment strategy, the trial was at risk of missing its critical milestones, delaying the drug’s potential launch.

Regulatory Approvals Were Delayed – Multi-country submissions took 45% longer than expected. The complexity of global regulatory requirements created multiple bottlenecks, requiring constant re-submissions and clarifications.

Site Compliance Issues – Over 12% protocol deviations and 3 critical compliance violations were recorded, increasing risk. These errors not only slowed down trial progress but also posed a significant risk to the integrity of the study results.

If these issues were not resolved, the trial could be delayed by at least 7 months, increasing costs by an estimated $8 million. That’s when they partnered with ProRelix Research.

Our Data-Driven Approach: How We Solved the Problem

We developed a customized strategy to optimize every aspect of the clinical trial.

 1. Patient Recruitment: 50% Faster Enrollment

One of the biggest challenges was recruiting 200 eligible patients within 7 months. Our team implemented a multi-channel patient recruitment strategy, ensuring faster and more effective engagement.

Data-Driven Records – We analyzed over 1000 patients records using data driving records analytics to identify high-potential candidates who matched the trial’s eligibility criteria. This reduced screening failures and improved recruitment efficiency.

Digital Recruitment Campaigns – We launched targeted digital campaigns on social media, healthcare platforms, and patient communities, increasing engagement by 25% compared to traditional recruitment methods. Personalized messaging helped attract motivated participants.

Site Expansion – By increasing the number of trial sites from 18 to 26, we ensured that more patients had access to the study. This strategic move resulted in a 30% increase in site-level recruitment rates, significantly improving overall enrollment speed.

Impact:

Recruitment increased by 50%, allowing the client to meet their target 4 months ahead of schedule.

Patient retention rate improved to 92%, reducing dropout rates and ensuring trial continuity.

Average enrollment time per site reduced from 3.2 months to 1.9 months, keeping the trial on track.

2. Regulatory Approval: 35% Faster Multi-Country Approvals

The Biotech firm was struggling with complex regulatory submissions across multiple regions. Our team streamlined the process to avoid delays.

Regulatory Submission Optimization – We ensured that every submission was error-free and fully compliant with the latest FDA, EMA, and DCGI guidelines. This eliminated the need for extensive rework and resubmissions.

AI-Driven Document Review – By integrating AI-powered tools, we reduced submission errors by 28%, ensuring quicker acceptance. These tools helped identify inconsistencies in regulatory documents before submission.

Direct Collaboration with Regulators – Our regulatory affairs specialists maintained continuous communication with global regulatory bodies, addressing queries in real time. This proactive approach cut down response times by 40%.

Impact:

Regulatory approval was secured 35% faster, reducing delays by 5 months and keeping the trial on track.

Error rate in submissions dropped from 14% to just 3%, ensuring smooth acceptance.

Back-and-forth communication with regulators reduced by 40%, saving time and effort.

3. Site Management: 60% Reduction in Compliance Issues

Poor site management and compliance issues were threatening trial integrity. We took a hands-on approach to resolve these challenges.

Real-Time Monitoring System – We implemented a centralized monitoring platform that allowed real-time tracking of all site activities. This led to a 60% reduction in protocol deviations by flagging issues before they escalated.

On-Site Staff Training – Our team conducted over 200 hours of GCP (Good Clinical Practice) training for site staff, improving adherence to trial protocols and reducing non-compliance.

Automated Data Capture – We introduced electronic data capture (EDC) tools, reducing manual errors and improving data accuracy by 42%. This ensured clean, reliable, and high-quality trial data.

Impact:

Protocol deviations reduced from 12% to just 4.5%, minimizing risks and improving trial credibility.

Query resolution time at sites improved by 55%, ensuring faster issue resolution and trial continuity.

Data quality scores improved by 33%, making the trial data more robust and reliable.

The Final Results: A Trial Turned Around

Thanks to the combined efforts of ProRelix Research and the client, the trial saw measurable improvements:

• Patient enrollment completed 2 months ahead of schedule, preventing costly delays.
• Regulatory approvals secured 5 months faster, accelerating market entry and reducing risk.
• Site compliance issues reduced by 60%, ensuring high-quality, reliable trial data.
• Total trial costs reduced by an estimated $5.2 million, increasing ROI for the sponsor.

A Step Closer to Saving Lives

With our expert support, the client successfully completed their Phase II trial on time, paving the way for regulatory submission and future commercialization.

Their confidence in our expertise, strategic approach, and commitment to excellence has led to a long-term partnership.

Why Choose Us?

We don’t just manage clinical trials—we empower companies to succeed with:

• Fast and effective patient recruitment – Ensuring the right patients are enrolled quickly and efficiently.
• Streamlined regulatory approvals – Reducing delays and ensuring compliance across multiple regions.
• Optimized site management – Enhancing trial execution with real-time monitoring and expert training.
• Cutting-edge technology and analytics – Leveraging AI and automation to improve data accuracy and efficiency.

Let’s make your clinical trial the next success story while contributing to global advancements in research. Be part of a network driving innovation and excellence in clinical trials.