Case Study: Fast-Tracking Enrollment for a Global Phase 3 Norovirus Vaccine Trial

Objective

Tekton was selected to deliver research sites and participants for a Global Phase 3 vaccine clinical trial. The study required a population of generally healthy adults and demanded rapid site activation and participant enrollment to meet aggressive study timelines.

Challenge

Norovirus, a highly contagious virus causing gastrointestinal illness, presents significant global public health challenges. With multiple competing vaccine studies running concurrently, Tekton faced a familiar challenge: recruit qualified, healthy adult participants faster and more efficiently than competitors, while maintaining regulatory compliance and operational excellence. The pressure was on to initiate sites, enroll participants, and deliver data—fast.

Solutions

Key Metrics

day
Average time from site activation to first patient visit across 7 sites (3 of 7 sites achieved this milestone in under 24 hours)
days
Average regulatory turnaround time across 7 sites
%
Average enrollment across 7 sites
Goal: 450 | Enrolled: >485

Accelerated Study Start-Up & Activation

Tekton’s centralized model ensured alignment across internal teams, sites, and sponsor stakeholders. By centralizing regulatory and IRB submissions, contracting, and budgeting processes, Tekton cut down on back-and-forth delays and launched with speed and confidence. Sites were supported every step of the way by a single point of contact and real-time dashboards to monitor progress and compliance.

Targeted Patient Recruitment

Tekton's approach to recruitment for vaccine studies begins long before vaccine season. Our dedicated Patient Recruitment Center in Austin, TX maintains a robust database of trial-ready individuals and stays in touch through regular outreach via email, phone calls, and text messages. By pre-identifying potential participants year-round and engaging with diverse communities through local events and initiatives, we ensure rapid enrollment and strong retention when it’s time to launch.

Results

Enrollment began and ramped up immediately following site activation. Tekton achieved an average time of just 1 day from activation to first patient screened across seven sites—with nearly half the sites achieving that milestone in less than 24 hours. Average regulatory turnaround across Tekton sites was just 5 days, a testament to Tekton’s operational efficiency and sponsor-aligned approach.

Tekton Sites

  • Beaumont, TX
  • Edmond, OK
  • Fort Collins, CO
  • Longmont, CO
  • San Antonio, TX
  • Wichita, KS
  • Yukon, OK
clinical research neurology studies

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