Optimizing eCOA Implementation for Vaccine Trial Success and Speed

Vaccine trials demand comprehensive longitudinal data collection from thousands of participants to accurately assess reactogenicity and immunogenicity endpoints. Traditional paper diary methods introduce transcription errors, delay data availability, and struggle to maintain participant engagement across 7-14 day reporting periods post-vaccination. How can sponsors accelerate timelines while ensuring regulatory-grade data quality at scale?

Dr. Stephan Bart, Executive Advisor for Infectious Disease and Vaccines at Signant Health, presents evidence-based strategies for implementing electronic clinical outcome assessment (eCOA) platforms in modern vaccine research. Drawing from experience supporting 95+ vaccine studies involving 140,000+ participants across 30+ countries—including pivotal COVID-19 vaccine trials—this presentation demonstrates how technology transforms vaccine trial operations and evidence generation.

Critical implementation guidance:

• Configuring reactogenicity diaries that capture real-time, time-stamped adverse event data with automated high-grade alerts
• Implementing BYOD (bring-your-own-device) strategies that achieved 80% uptake and regulatory acceptance
• Designing long-term disease surveillance protocols that maintain participant engagement across extended follow-up periods
• Leveraging automated reminders and intuitive interfaces to drive completion compliance while reducing operational costs

Essential viewing for clinical operations teams, vaccine developers, and regulatory affairs professionals managing large-scale immunization studies.