Selected as a participating site network for a Phase 3 Pneumococcal Vaccine trial, DelRicht Research was entrusted with enrolling healthy, pneumococcal-naïve adults across two specialized sites.

From challenges including strict “pneumococcal-naïve” verification requirements for older populations and the technical barriers of 24-hour eDiary windows, DelRicht Research delivered through refined intake screening, proactive medical record verification, and hands-on digital literacy support for our participants. Our teams continue to demonstrate what operational precision and patient engagement can achieve in large-scale vaccine trials.

Surpassing Enrollment Expectations

The sponsor’s national goal for this Phase 3 study was to recruit 4000 patients ≥18 years of age across 30 sites. DelRicht’s sites, led by Dr. Patrick Dennis at Touro Medical Center and Dr. Sean Kerby at Gulfport Memorial, were expected to enroll 266 participants. By the end of the enrollment period, the two sites had enrolled 337 participants, 126% of the assigned goal.

Navigating Complex Recruitment Barriers

Like many large, multi-site clinical vaccine trials, the study presented several operational and recruitment complexities that posed challenges to both enrollment and overall execution.

– Pneumococcal-Naïve Recruitment: Strict eligibility criteria requiring no prior IPD, pneumonia diagnosis, or pneumococcal vaccination, combined with the need for verification via records/registries, significantly narrowed the eligible pool, particularly in the 65+ population.

– eDiary Management: A 7-day eDiary with strict 24-hour completion windows required intensive oversight. Email-based diary access created usability barriers, particularly among older populations with limited email access or digital literacy.

Targeted Strategies to Drive Recruitment and Compliance

DelRicht addressed these challenges through a combination of operational discipline, community engagement, and tailored recruitment strategies:

– Optimized Recruitment: Reduced screen failures by refining intake to capture key exclusion criteria (e.g., prior pneumonia) upfront, pre-identifying pneumococcal-naïve patients via database and medical record review, and cross-verifying vaccination history. Multi-channel outreach and centralized call center guides patients from interest to enrollment. WIth ~10 leads required per qualified pre-screen, our team scaled capacity to be able to contact a high volume of patients, all within 10 minutes of indicating interest, driving high conversion to meet enrollment goals.

– Facilitated eDiary Compliance: Enhanced diary compliance through a comprehensive approach combining proactive daily monitoring and rapid follow-up with hands-on patient education (email setup, navigation guidance, and personalized reminders), such as flagging diary emails at randomization to minimize missed entries.

Full Enrollment, High-Quality Data, and Network-Wide Impact

Through these combined efforts, DelRicht successfully enrolled 337 participants across two sites, achieving 126% of the study’s enrollment goal within a focused 3.5-month period and had first patient screening the same day as enrollment opening.

While many sites in similar studies face delays due to recruitment barriers or operational inefficiencies, DelRicht’s embedded model enabled consistent performance across locations, ensuring both speed and data integrity.

What This Means for Sponsors and CROs

This study reinforces key advantages of working with a fully aligned site network:

– Rapid start-up timelines are achievable with centralized coordination and experienced teams.
– Recruitment barriers, whether behavioral, clinical, or logistical, can be mitigated with tailored, site-level strategies.
– Complex populations require intentional expertise and education, not one-size-fits-all approaches.
– Proven enrollment performance that consistently exceeds expectations, ensuring studies are powered efficiently.

Partner With DelRicht Research

From start-up to quality data capture, DelRicht Research delivers the infrastructure, experience, and adaptability required for today’s most complex vaccine trials. If you’re planning an upcoming study, our team is ready to help you accelerate timelines, improve enrollment outcomes, and maintain data quality from start to finish. Learn more at www.DelRichtResearch.com or connect with us to discuss your next vaccine trial.