CASE STUDY: Improving Clinical Trial Site Engagement and Patient Recruitment in a Complex Pancreatic Cancer Study
Executive Summary
How Stiris aligned multi-department clinical trial teams to accelerate study start-up and complete patient recruitment ahead of schedule.
Therapeutic area: Oncology
Indication: Pancreatic Cancer
Location: United States
Challenge: A complex clinical trial involving multiple departments created delays in study start-up, site alignment, and communication, putting patient recruitment timelines at risk.
Result: Stiris improved clinical trial site engagement, aligned cross-functional teams, and enabled patient recruitment completion one month ahead of schedule.
Challenge
Stiris Research was selected to provide clinical trial management and medical monitoring services for a pancreatic cancer clinical trial across three U.S. sites.
This complex oncology trial required coordination across multiple departments, including Medical Oncology, Radiation Oncology, Surgical Oncology, Nuclear Medicine, Endoscopy, Pharmacy, Lab, and Pathology, groups that do not typically operate as a unified clinical trial team.
Complex clinical trials like this often face delays due to multi-department coordination challenges, lack of site alignment, and inefficient communication workflows. Without strong clinical trial site management, these factors can significantly impact study start-up timelines and patient recruitment.
Key challenges included:
- Lack of experience operating as a single, cohesive clinical trial unit across departments
- Misalignment in Principal Investigator (PI) ownership between Medical Oncology and Surgical Oncology
- Limited communication structures between departments, slowing decision-making
- Extended timelines (up to one year) for contracts, budgets, IRB approvals, and departmental sign-offs
- Risk of site disengagement during a prolonged and complex start-up phase
Solution
Stiris implemented a high-engagement clinical trial site management strategy focused on alignment, communication, and operational efficiency.
- Early Stakeholder Alignment Across Clinical Trial Teams
Stiris identified key stakeholders and decision-makers across all departments early in the process, ensuring efficient coordination and faster approvals across complex institutional structures.
- Proactive Clinical Trial Planning and Sponsor Alignment
Stiris worked closely with the sponsor to address site questions quickly and maintain consistent communication. This alignment reinforced a unified CRO-sponsor approach and increased site confidence in the study.
- High-Touch Clinical Trial Site Engagement
Frequent, structured communication with site coordinators helped identify operational barriers early, gather feedback, and adapt processes to site-specific needs — a critical factor in maintaining clinical trial site engagement.
- Cross-Functional Communication Enablement
Stiris established clear communication pathways between departments, enabling real-time updates and improving collaboration across clinical trial teams that do not typically work together.
- Real-Time Study Start-Up Tracking and Oversight
Using the Stiris CTMS Study Start-Up Tracker, the team maintained real-time visibility into regulatory documentation, IRB approvals, committee reviews, and vendor requirements — enabling proactive timeline management.
- Site-Centric Clinical Trial Execution
Stiris adapted the study to fit site workflows rather than forcing rigid processes, reducing operational friction and improving execution across all sites.
Results
- Sustained Clinical Trial Site Engagement
Sites remained engaged and responsive throughout a prolonged start-up phase, avoiding common drop-off seen in complex oncology trials.
- Improved Cross-Department Clinical Trial Collaboration
Departments successfully operated as a coordinated clinical trial unit, improving efficiency in approvals and execution.
- Operational Continuity Despite Staff Turnover
Even with significant turnover at the site level, clinical trial operations continued without disruption due to strong communication and support.
- Enhanced Study Start-Up Visibility and Control
Real-time tracking tools enabled proactive management of study timelines, reducing delays in approvals and documentation.
- Accelerated Patient Recruitment
Strong site relationships and engagement led sites to prioritize the study, resulting in patient recruitment completion one month ahead of schedule.
Sponsor Impact
Stiris transformed a complex, multi-department clinical trial into a coordinated and high-performing operation.
By improving clinical trial site engagement, aligning stakeholders, and optimizing start-up processes, Stiris reduced execution risk, protected timelines, and accelerated patient recruitment in a challenging oncology study.
Key Takeaways
- Strong clinical trial site engagement improves recruitment performance
- Early stakeholder alignment reduces study start-up delays
- Cross-functional communication is critical in complex oncology trials
- Site-centric approaches improve execution and reduce operational friction
- Real-time tracking enables proactive clinical trial management
- Sponsor-CRO alignment strengthens site trust and performance
Protect Your Critical Trial Milestones
Delays in clinical trial start-up, poor site engagement, and misaligned teams can significantly impact patient recruitment and study timelines.
Stiris Research specializes in clinical trial site management, site engagement strategies, and start-up optimization to help sponsors accelerate timelines and improve recruitment outcomes.
Connect with Stiris Research to improve site performance, reduce delays, and maximize your clinical trial success.