Case Study | Pandemic Success | High Enrollment Goal Met

Pandemic Success

High Enrollment Goal Met

Issue

How to meet aggressive enrollment goals when pandemic stalls enrollment

Sponsor

US-based, clinical stage, biotechnology healthcare company

Project

High-enrolling, time-driven, mega-trial comprised of a population at risk of disease (cancer) involving 11 US-based sites and enrolling nearly 6700 participants

Challenge

  • Pandemic requiring a shift in site monitoring approach
  • Fast-paced timelines and high volume of data
  • Multiple interim analyses with overlapping timelines
  • Management of site fatigue

Solutions

  • Assess site capacity to accommodate remote monitoring – create customized approach
  • ­Established strong relationships with active sites– a ProTrials core strength
  • Balance high volume client requests while being mindful of site capacity
  • Conduct root cause analysis to boost participant compliance
  • Detailed CRA resource/visit tracking to meet project deliverables

Results

  • Exceeded enrollment goals
  • Data quality surpassed client expectations
  • High participant compliance
  • Met project goals and deliverables on time
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